Publications

Outcomes in acute carotid-related stroke eligible for mechanical reperfusion: SAFEGUARD-STROKE Registry

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• Registry comparing CGuard Endovascular Stroke Treatment (EST)-treated patients vs untreated patients over an 8-month period.
• Clinical committee (clinical and images) determined EST-eligibility (NIHSS ≥6; ASPECT >6; mRS ≤2) + assessed ICA stenosis or occlusion by CTA.
• 101 patients: 43% EST-treated vs. 57% non-EST-treated.
  Patient characteristics:
• Comparable between the 2 groups.
• Symptoms onset to presentation (all patients): median 5hrs (3-8).
• Patients with or without concomitant intracranial LVO.

Referral and rejection:

• More than half (57%) of EST-eligible patients are not referred for brain-saving EST treatment.
• Comprehensive Stroke Centers (ie. INR) rejected 81% of EST-eligible patients referred to them; VS rejected 19% of them.
• VS Guidelines for acute CRS: CEA delayed for at least 7 days if IVT has been administered. Risk of recurring stroke while waiting is ~20%.

Highlights

• Endovascular Stroke Treatment with CGuard of acute Carotid Related Stroke (CRS) is safe and effective: 84% independent at 90-day (vs. 35% if no EST).
• Thrombectomy-capable centers with CAS expertise should be included in the stroke referral and management pathway.

Next-Generation TransCarotid Artery Revascularization: TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System To Reduce Strokes – TOPGUARD Study

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Prospective analysis of 106 consecutive patients with high-grade carotid stenosis, symptomatic and asymptomatic, at high risk for CAS and standard risk for CEA treated at 3 European centers of excellence. BACKGROUND A metanalysis* of TCAR with the ENROUTE NPS (18 studies and 4,852 patients) with approved stents (Precise, etc.) showed: • a periprocedural death/stroke rate of 5% at 30-day. • a stroke/TIA rate of 1.9% at 30-day, with a statistically significant difference between symptomatic and asymptomatic patients, 2.5% and 1.2%, respectively.*

Highlights

TCAR with the Enroute NPS and the CGUARD stent demonstrated 30-day rates of:
• Stroke = 0.9% (1/106)
• Death/Stroke = 0.9%
• DSMI = 0.9%
• Comprised of 1 minor stroke, no MI and no death
• The minor stroke was caused by damage to the intima during the arterial sheath introduction before the ENROUTE cerebral protection was established.
• In symptomatic patients (n=64; 60.4%): DSMI = 0%

Data suggests that combining flow reversal with CGUARD stent during TCAR has the potential to (1) improve outcomes, (2) equalize outcomes between symptomatic and asymptomatic patients.

A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE

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• 7 centers in Europe enrolled 75 consecutive patients over 12 months. • All patients had acute ischemic strokes (AIS) of carotid artery origin, eligible and referred for emergency recanalization. • All patients had (1) their stroke treated by thrombectomy alone or in combination with a stentriver and (2) their carotid stenosis or occlusion treated with CGuard (CAS or TCAR). At the operator’s discretion (real world): • Access (femoral: 89%, radial: 7%, TCAR: 4%), • anesthesia (GA: 55%; CS: 45%), • cerebral protection (none: 55%, proximal: 40%, distal: 4%, both: 3%), • pre-dilatation (yes: 39%), • post-dilation (yes: 96%) but balloon size and peak pressure variable, • type and timing of medications variable (e.g. heparin 100% but variable doses, DAPT 95%, DAPT start <24hrs 54%, etc.), • tandem approach (retrograde: 69%, anterograde: 31%) Angio corelab: • pre (ICA type of lesion, thrombus, calcification) and post (mTICI grading) Baseline characteristics: • Tandem (52%) vs. isolated carotid (48%) lesions • ASPECTS on admission: 9 (8-10) • NIHSS on admission: 14 (12-19) • ICA lesion type: atherosclerosis (89%), dissection (7%) • ICA thrombus: 63% • ICA severe calcification: 15%

Highlights

• Technical success (delivery, implant, retrieval and <30% residual): 100%
• Clinical success (no DSMI, sICH, loss of ICA patency at discharge): 83%
• Final mTICI: 2b/c (23%) and 3 (67%)
• New stroke by 90-day: 3% (n=2)
• ISR at 90-day: 8% (n=5)
• Predictor of ISR: balloon size < 5mm and mTICI <2b

Carotid artery revascularization using second-generation stents versus surgery: a meta-analysis of clinical outcomes

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This Vascular Meta-analysis compares second-generation stent CAS (SGS CAS) with RCT-CEA (CEA from Randomized Control Trials) and VQI-CEA (CEA from Vascular Quality Initiative Registry) End Points are 30-day Stroke and Death/Stroke/MI (DSM), and 12-month Ipsilateral Stroke (IS) and In-Stent Restenosis (ISR

Highlights

• Compared to RCT-CEA, SGS as a group reduces 30-day Stroke in 1.92% ARR (2.52% RCT-CEA vs. 0.60% SGS; RRR 76%). CGuard™ reduces 30-day Stroke in 1.98% ARR (2.52% RCT-CEA vs. 0.54% CGuard), RRR 78%*.
• Compared to RCT-CEA, CGuard™ reduces 12 months ipsilateral stroke/restenosis in 3.16% ARR (3.89% RCT-CEA vs. 0.73% CGuard), RRR 82%*, SGS Best-in-class.
• Variable effect within the SGS class when compared to RCT-CEA

Vascular surgery study of the CGuard in patients with indication to carotid revascularization: POLGUARD

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POLish Vascular Surgery CGUARD Study (POLGUARD) is an independent, prospective, open-label, single-arm study that enrolled 204 consecutive patients with 30-day clinical and doppler follow-up.

Highlights

• DSMI at 30-day: 1.48% (3/204).
• There were 3 minor strokes, no major strokes, no death, no MI at 30-day
• 100% patency at 30-day

The Study from a large-volume vascular surgery center demonstrates that CGuard is safe and effective.

SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study

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Sixty (60) patients with concomitant severe coronary and carotid stenoses were treated with simultaneous CABG (under CEC) and Carotid Revascularization (hybrid-room).

Highlights

At 30-days Freedom from stroke 88.3% (7 strokes (11.7%)) and Freedom from death 93.3% (4 deaths (6.7%)). The CGuard stent patency was 100%.
Simultaneous open-chest extracorporeal circulation and CAS with CGuard is feasible and safe.

The role of post-dilatation in CGuard stent implantation, evaluated using 3D cone-beam CT angiography

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192 patients presenting with different types of plaque were evaluated at baseline, before, and after post-dilatation: calcified N= 56; fibro-lipidic mixed density plaque N=72; lipidic with soft plaque N=65

Highlights

After post-dilatation, 3D cone-beam CT reported a significant increase in the luminal cross-sectional area, consistent across all plaque types. No DSMI at discharge.

CGuard stent post-dilatation is safe and consistently increases luminal cross-sectional areas in carotid lesions of various plaque types.

One-Year Outcomes of CGuard Double Mesh Stent in Carotid Artery Disease: A Systematic Review and Meta-Analysis

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Konstantinos Tigkiropoulos et al. performed a systematic review and meta-analysis. Seven (7) studies were selected, based on quality criteria through a rigorous selection process and presented in a PRISMA flow diagram. The primary endpoints were death (all-cause, cardiovascular and ipsilateral stroke-related death) and ipsilateral stroke rate at 1-year. The secondary endpoint was in-stent restenosis at 1-year. The total number of subjects was 1,709 (1,742 arteries, mean age 71.6 years, 71.1% men). The 1-year follow-up was 99.4%.

Highlights

The main results were:

• The 1-year all-cause mortality rate was 2.97%
• The 1-year ipsilateral stroke rate was 1.21%
• The 1-year in-stent restenosis rate was 1.06%

 The authors concluded that “this meta-analysis shows that CAS with CGuard is safe with minimal neurological adverse events and in-stent restenosis rate at 1 year.”

12-Month Outcomes of Carotid Artery Stenting With CGuard MicroNET-Covered Stent: A Single-Center Study in 113 Patients

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This prospective study aims to report 12 months outcomes of 113 consecutive patients who underwent CAS with CGuard MicroNET covered stent from October 2018 to March 2022. Primary endpoints included in-stent restenosis >70% verified by ultrasound (DUS), ipsilateral transient ischemic attack (TIA), and stroke at 12 months. Secondary endpoints included cardiovascular-related mortality (stroke, myocardial infarction, heart failure) and all-cause mortality during follow-up.

Highlights

CAS with CGuard MicroNET covered stent is safe with minimal neurological adverse events at 12 months follow-up:

• 0.8% In-stent restenosis,
• 0.8% Ipsilateral stroke,
• 0% External carotid artery occlusion,
• 2.6% Cardiovascular-related mortality.

Randomized Controlled Trial of Conventional Versus MicroNet™-Covered Stent in Carotid Artery Revascularization – 12Month Outcomes

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Prospective 1:1 randomized controlled study, independent investigator-initiated study, single-center, externally monitored, and imaging data evaluated by an independent core laboratory. 100 consecutive unselected patients randomized to 50 Acculink™ and 50 CGuard™. Primary endpoint: MRI identified new ischemic brain lesions after CAS within 24-48 hours and 30 days. Secondary endpoint: Technical success, major adverse events (death, stroke, myocardial infarction) during the procedure, post-procedural, 24-48 hours, 30 days, and 12 months @48hr DW-MRI CGuard™ vs. Acculink™ o significant fewer and smaller brain lesions in CGuard™: o the CGuard™ arm was observed to have a 78% reduction in the average volume of new cerebral lesions, a statistically significant improvement (p=0.007) @30-day CGuard™ vs. Acculink™: o persistent reduction of lesion number in CGuard™ o reduction of the total volume of permanent cerebral lesions by 92.3% (P < 0.001) in CGuard™ 12-months CGuard™ vs. Acculink™: •0 in stent restenoses (ISR), 0 occlusion in CGuard™ arm, 3 in-stent restenoses (ISR), 1 occlusion in Acculink™ arm.

Highlights

• These data constitute level 1 evidence in favor of CGuard™ MicroNet™-covered stent in demonstrating the reduction of cerebral infarcts in neuroprotected CAS versus CREST Stent (Acculink™).
• The postprocedural embolism was totally eliminated with the CGuard stent; in contrast, it persisted with the Acculink stent.
• Thanks to MicroNet™-covered carotid stent CGuard™, lower periprocedural stroke rates and the elimination of postprocedural neurologic events by 30 days
• 12-month clinical outcomes from a randomized controlled trial of cerebral embolism in CAS using the CGuard vs the CREST trial stent suggest that MicroNet™-covered stent use may be associated with a clinical benefit.
• Consistency in terms of the 12-month CGuard™ and Acculink™ outcomes with the meta-analysis (112 CAS studies with a total of 68,422 patients).

Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis

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A systematic literature review of clinical studies from 1 Oct 2004 to 31 Oct 2019. 68,043 patients (44,9% symptomatic) included in 112 eligible studies meta-analyzed. • To compare dual layer, “mesh stents” (Second-Generation-Stent SGS): Casper/Roadsaver, Gore Mesh Stent, and CGuard MicroNet™ Stent) vs single metallic layer stent (open-closed cell First-Generation-Stent FGS) in stroke prevention at 30-day and 12-month • End Points evaluated: 30-day (stroke and death/stroke/MI), and 12-month outcomes (ipsilateral stroke and in-stent restenosis).

Highlights

• 30-day clinical outcomes: SGS as a group (n =2531) showed a benefit in 30-day stroke and 30-day death/stroke/MI vs. FGS (open or closed cell)
• 12-month clinical outcomes: only the SGS CGuard™ showed a reduction in both Ipsilateral Stroke and InStent Restenosis (p < 0.01) vs. FGS, Casper/Roadsaver reduced IS (p < 0.05) but increased ISR (p= 0.04) vs. FGS (open or closed cell)
• These findings indicate a lack of “mesh stent” class effect.

Randomized Controlled Trial of Conventional Versus MicroNet™-Covered Stent in Carotid Artery Revascularization

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Prospective 1:1 randomized controlled study, independent investigator-initiated study, single-center, externally monitored, and imaging data evaluated by an independent core laboratory. 100 consecutive unselected patients randomized to 50 Acculink™ and 50 CGuard™. Primary endpoint: MRI identified new ischemic brain lesions after CAS within 24-48 hours and 30 days. Secondary endpoint: Technical success, major adverse events (death, stroke, myocardial infarction) during the procedure, post-procedural, 24-48 hours, 30 days, and 12 months @48hr DW-MRI CGuard™ vs. Acculink™ o significant fewer and smaller brain lesions in CGuard™: o the CGuard™ arm was observed to have a 78% reduction in the average volume of new cerebral lesions, a statistically significant improvement (p=0.007) @30-day CGuard™ vs. Acculink™: o persistent reduction of lesion number in CGuard™ o reduction of the total volume of permanent cerebral lesions by 92.3% (P < 0.001) in CGuard™

Highlights

• These data constitute level 1 evidence in favor of CGuard™ MicroNet™-covered stent in demonstrating the reduction of cerebral infarcts in neuroprotected CAS versus CREST Stent (Acculink™).
• The postprocedural embolism was totally eliminated with the CGuard stent; in contrast, it persisted with the Acculink stent.
• Thanks to MicroNet™-covered carotid stent CGuard™, lower periprocedural stroke rates and the elimination of postprocedural neurologic events by 30 days

5-Year Clinical and Ultrasound Outcomes in CARENET Prospective Multicenter Trial of CGuard MicroNet™ Covered Carotid Stent

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CARENET (CARotid Embolic Prevention using MicroNet™-Covered Stent System in Patients with Symptomatic and Asymptomatic Carotid Artery Stenosis) was the first multicentric, multispecialty, prospective single-arm trial of CGuard™. Clinical evaluation and duplex ultrasound imaging (30 days, 6 months, 1 and 5 years) were performed by an independent neurologist and a certified ultrasonographer.

Highlights

In the CARENET trial population at 5 years follow up, the MicroNet™-covered stent CGuard™ use was associated with:
• Sustained ipsilateral stroke prevention.
• A durable anatomical reconstruction of the carotid artery
• Absence of in-stent restenosis (normal healing)
• Absence of external carotid artery occlusion (uncompromised side-branch)

Anatomical Modifications After Stent Implantation: A Comparative Analysis Between CGuard, Wallstent, and Roadsaver Carotid Stents

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Carotid revascularization can be associated with modifications of the vascular geometry, which may lead to complications. The study prospectively recruited 217 consecutive patients (112 CGuard, 73 WallStent, and 32 RoadSaver, respectively). The changes on the vessel angulation before and after a carotid WallStent (WS) implantation are compared against two new dual-layer devices, CGuard (CG) and RoadSaver (RS).

Highlights

• CGuard determines minor changes over the basal morphology than WallStent and RoadSaver stents.
• CGuard respects better the native vessel anatomy than the other stents.
• For CGuard, no statistical difference in the axial vessel geometry between the basal and postprocedural angles was found.
• For WallStent and RoadSaver, statistical difference was found between pre- and post-angles.
• CGuard induces lower changes from the original curvature with respect to WS and RS.

Randomized Controlled Trial of Conventional Versus MicroNet™-Covered Stent in Carotid Artery Revascularization

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The randomized control trial evaluated 30-day silent brain infarcts associated with the use of the Acculink conventional open-cell nitinol stent vs the CGuard MicroNet™-covered stent. The MicroNet™-covered stent significantly reduced periprocedural cerebral embolism, showing an average of 57% reduction in lesion per patient (171 mm3 vs 73 mm3 (P = 0.017)) and a 4.5 fold reduction in total volume of periprocedural lesions (701 mm3 vs 157 mm3 (P = 0.007)) when compared to Acculink. Additionally, postprocedural (48 hours to 30 day) cerebral was abolished by the MicroNet™ covered stent, while it was ongoing with the conventional, first-generation carotid stent.

Highlights

CGuard MicroNet™-covered carotid stent, in relation to a first-generation stent:
• Reduced 4.5-fold the magnitude of peri-procedural silent brain infarcts volume; and
• Abolished post-procedural silent infarcts, that were on-going with the first-generation stent.
• This data constitutes level 1 evidence in favor of a CGuard MicroNet™-covered stent in demonstrating reduction of cerebral infarcts in neuroprotective CAS versus Acculink.

1-Year Results from a prospective Experience on CAS Using the CGuard stent system the IRONGUARD 2 Study

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This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS).

Highlights

IRONGUARD 2 represents, to date, the largest prospective multicenter multispecialty registry on the use of mesh-covered stents. More than 700 consecutive CAS patients were enrolled during the study period, treated using the CGuard DLS, and followed for 12 months.
The 1-year results of the IRONGUARD 2 study suggest that the use of CGuard™ could make it possible to achieve low rates of MACE and restenosis, regardless of patients’ clinical and anatomical features or the procedural techniques adopted.

Thirty-Day Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting

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The aim of this study was to provide early-term evaluation, safety, and efficacy of the novel CGuard™ micromesh self-expanding stent with embolic protection system (EPS) during carotid artery stenting (CAS) procedure.

Highlights

• Technical success rate was 100%
• 2.Periprocedural TIA was 1.9%
• 0% minor/major stroke
• Embolic protection devices were used in 5.8%.
• 0% 30-day MAE

Transient flow reversal combined with sustained embolic prevention in transcervical revascularization of symptomatic and highly-emboligenic carotid stenoses for optimized endovascular lumen reconstruction and improved peri- and post-procedural outcomes

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The present technical note, with its imaging and clinical correlates, describes how to (1) achieve an effective proximal cerebral protection through a transcervical access transient flow reversal kit based on consumables routine in vascular surgery and interventional vascular medicine, and (2) optimize its use by pairing it with the MicroNet™-covered stent system for an effective plaque sequestration with endovascular lumen reconstruction and sustained embolic revention

Highlights

Using routinely available vascular surgery and endovascular angiology equipment and tools for transient flow reversal to protect the brain from intra-procedural embolism, paired with the use of MicroNet™-covered embolic prevention stents to exclude the symptomatic plaque from the lumen, enable an effective restoration of normal anatomy with prevention of plaque-related embolism. Use of a plaque-insulating stent system overcomes limitations of 1st generation carotid stents, increasing the spectrum of carotid lesions routinely suitable for endovascular stent-assisted lumen reconstruction to include highly-emboligenic lesions for which CEA has been a historic first choice. The optimized medical therapy alone is not sufficient to effectively prevent strokes in relation to atherosclerotic carotid stenosis, minimally-invasive and clinically-effective peri-procedural and post-procedural prevention of post-procedural cerebral embolism (and thus post-procedural stroke risk prevention), taken together with improved stroke risk stratification at the lesion and patient level, may soon transform the field of stroke prevention in relation to carotid artery stenosis. It is clear today that the transcervical flow reversal approach to CAS will need to incorporate advances in the carotid stent design that, as  accumulating evidence shows, translate into improved peri- and post-procedural cerebral outcomes.

1-Month Results from a Prospective Experience in CAS Using CGuard Stent System: The IRONGUARD 2 Study

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From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard™embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates.

Highlights

IronGuard 2, real-world registry, suggests that use of CGuard™ embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.

Use of Dual-Layered Stents for Carotid Artery Angioplasty 1-Year Results of a Patient-Based Meta-Analysis

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This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS). The authors performed an individual patient–level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year.

Highlights

Patients were divided into 2 groups: Roadsaver™ (RS), 250 patients and CGuard™ (CG), 306 patients. At 1 year 7 patients died in the group Roadsaver™ (2.8%) and 4 patients in the CGuard™ one (1.31%); death and stroke rate was: 11 events in the Roadsaver™ group (4.4%) and 10 in the CGuard™ group (3.27%). At 1 year, restenosis occurred in 10 in the Roadsaver™ group (4%) and 2 in the CGuard™ one (0.65%) (p = 0.007).

Routine MicroNet™-covered embolic prevention stent system use for consecutive symptomatic and increased stroke-risk asymptomatic carotid stenosis revascularization: Twelve-month outcomes from the PARADIGM study.

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PARADIGM is a non-industry-funded, prospective academic study in all-referrals-tracked symptomatic and asymptomatic carotid stenosis with a multi-specialty NeuroVascular Team (NVT,angiologist/cardiologist, vascular surgeon, eurologist) decision-making on revascularization including establishment of indication and endovascular approach feasibility assessment. The study enrolled unselected, consecutive patients with an independent neurologist evaluation at baseline, peri-procedurally and at 1 and 12 months, and with events adjudication by an independent Clinical Events Committee (CEC).

Preliminary Results From a Prospective Real-World Multicenter Clinical Practice of Carotid Artery Stenting Using the CGuard Embolic Prevention System: The IRONGUARD 2 Study

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Highlights

This real-world large multicenter, multispecialty analysis suggests that use of the CGuard EPS in routine clinical practice is associated with no major periprocedural and 30-day neurologic complications.

Highly-calcific carotid lesions endovascular management in symptomatic and increased-stroke-risk asymptomatic patients using the CGuard™ dual- layer carotid stent system: Analysis from the PARADIGM study

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The PARADIGM study is prospectively assessing routine CGuard use in all-comer carotid revascularization patients; the focus of the present analysis is highly-calcific carotid stenosis (HCCS) versus non-HCCS lesions.

Highlights

101 consecutive patients (51- 86 years, 54.4% symptomatic; 106 lesions) received CAS (16 HCCS and 90 non-HCCS); eight others (two HCCS) were treated surgically. The paper illustrates CGuard HCCS endovascular management was feasible and safe. A novel

Initial Clinical Results and In Vitro Testing of the New CGuard MicroNet™-Covered “One-Size-Fits-All” Carotid Stent

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To evaluate a MicroNet™-covered stent designed for the carotid artery with the new ability to adjust to different vessel diameters. The new self-adjusting, MicroNet™-covered stent has high conformability combined with an almost equivalent radial force at expansion diameters ranging from 5.5 to 9.0 mm. The first clinical results demonstrate that the new One-Size-Fits-All stent can be safely implanted in internal carotid arteries with reference diameters within this range.

Highlights

CGuard was successfully implanted in all 30 patients without periprocedural  complications, including no neurological events within 30 days. The chronic outward force normalized by stent length demonstrated a near-equivalent radial force outcome: The stent displayed only a minor difference between the minimal radial force at 9.0 mm (0.195 N/mm) and the maximal radial force at 5.5 mm (0.330 N/mm).

Micro-mesh technology in routine CAS: the final piece of the puzzle?

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Speziale et al report their experience in a real-world registry of patients undergoing protected CAS with the CGuard™ Embolic Prevention System. The present report, together with the growing literature about double-mesh stents, perfectly illustrates how the scenario of CAS has actually changed. With the procedural and 30-day risk further confirmed to be <1%, significantly lower than the five-year risk associated with the natural history of the disease, a decision on whether to offer intervention on top of optimal medical therapy should be considered in the earlier phases, when the natural his- tory of the disease (i.e., asymptomatic status) has not yet irreversibly compromised the patient’s quality of life.

Highlights

This report highlights the need for a quality control of the procedures. Technological advances, including mesh-covered carotid stents for sustained embolic prevention and temporary protection devices, should always be evaluated in the context of a standardised and tailored approach for each different patient and each different lesion. With this aim in mind, operators’ experience and training are crucial, both in patient/lesion selection and in appropriate device choice. The unique opportunity of having a completely “protected” procedure, which extends up to 30 days from the stent deployment, is now possible thanks to developments in stent technology and definitely demands that CAS procedures be performed by experienced and trained operators tailoring their strategy to patients’ anatomical and clinical characteristics

Twelve-month results of the Italian registry on protected CAS with the mesh-covered CGuard stent: the IRON-Guard study

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The IRON-Guard registry has continued to collect data from the first 200 patients treated by CGuard stent implantation. The present paper reports the one-year follow-up data completed by all patients. The IRON-Guard registry has confirmed the role of the CGuard MicroNet™ covered embolic prevention stent in lowering CAS-related neurological complications at 12-month follow-up, even in high-risk composition carotid plaques.

Highlights

No neurological CAS-related complications at 3, 6, and 12 months, in accordance with the 2.5% 

post-procedural minor stroke rate previously reported, thus confirming that a mesh-covered stent may stabilise any debris or embolic particles of the carotid plaque, even in highly embologenic ones, from the moment of stent opening until the completion of the plaque healing period and beyond, namely three months after the procedure, when it is supposed that the stent endothelialisation is completed. Moreover, no stent thrombosis or external carotid occlusion was registered, thus substantiating the hypothesis that mesh-covered stents are safe and effective in treating atherosclerotic lesions encountered at a carotid bifurcation and of internal origin . The ghost of restenosis seems to have been scared away in new-generation covered stenting: the 0.5% rate of restenosis at one year.

Early carotid artery Stenting after Onset neurologic symptoms

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This review summarizes the indications and results of early carotid artery stenting after onset of neurologic symptoms, considering the new carotid stents and cerebral protection systems available for clinical use and enhanced stenting techniques.

Highlights

Multicenter clinical trials level 1 evidence favors the application of carotid endarterectomy in symptomatic patients, especially the in the elderly cohort. Carotid artery stenting has been proposed as a possible early alternative in selected patients after onset of ipsilateral neurologic symptoms. It is well known that treatment of acute stroke is time-dependent in patients with acute ischemic stroke caused by high-grade stenosis of the internal carotid artery, but intensive medical treatment in conjunction with intervention to improve stroke severity and clinical outcomes has not been established. Two major clinical concerns exist: (1) the risk of hemorrhagic infarction after cerebral revascularization in the acute stage and (2) application of carotid stenting in the acute embolic stage, which may be associated with continued embolic risk after carotid artery stenting compared to carotid endarterectomy, which removes the symptomatic plaque.

Use of Dual-Layered Stents in Endovascular Treatment of Extracranial Stenosis of the Internal Carotid Artery

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This analysis was performed of multiple electronic databases for studies larger than 100 cases of CAS with DLS. Four single-arm prospective studies were identified, and individual patient data were collected. The primary endpoint was the occurrence of stroke at 30 days; secondary endpoints were technical and procedural success, periprocedural stroke, and in-hospital and 30-day rates of death.

Highlights

This meta-analysis suggests that dual-layered mesh-covered carotid stent systems can be safely used for CAS, and their use minimizes the incremental risk related to symptomatic status and other risk factors.

“One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered stents transforms the carotid revascularisation field”

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Comprehensive Review of Clinical Trial Data Supports the Safety and Efficacy of Carotid Artery Stenting (CAS) Versus Carotid Endarterectomy (CEA)Highlights. The review finds that data from more than 550 patients in mesh-covered and dual layered carotid device clinical studies show an overall 30 -day complication rate of ~1% with near-elimination of post-procedural events.

Highlights

The paper illustrates that carotid artery stenting (CAS) is rapidly becoming an equally safe, less invasive, better alternative to the surgical Carotid Endarterectomy (CEA) procedure.

Will mesh-covered stents help reduce stroke associated with carotid stent angioplasty?

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Carotid stenting offers an alternative option of burden disease, but the periprocedural risk of stroke is higher with CAS than CEA.

Highlights

It appears that this risk can be reduced, at least in part, with specific carotid stent designs that include a mesh covering to procedure the smallest possible open area to prevent ongoing embolization through the carotid stent. It is likely that as stent design improves and embolic debris is better controlled, the use of stenting will expand significantly

Letter by Musialek et al. Regarding Article “Occlusions of Dual-Layer Carotid Stents After Endovascular Emergency

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CGuard, with PET 20μm-only MicroNet™ positioned outside the nitinol stent frame, and its self-adapting ability to match vessel anatomy and diameter.

Highlights

Overall, following 307 CGuard implantations by our teams, including 49 implants in acutely symptomatic or thrombus-containing lesions, we observed no ST whatsoever.

Residual plaque prolapse with novel dual-layer carotid stents: is it mesh-covered or not?

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MicroNet™ covered carotid stent systematic per protocol DW-MRI evaluation demonstrated minimisation of intraprocedural embolisation and elimination of post-procedural cerebral embolisation10. This strategy has been termed intraprocedural and post-procedural (sustained) “embolic prevention” in CAS

Highlights

PET-fibre MicroNet™, positioned outside the stent frame and fixed to the frame only at the proximal and distal stent edge that has the ability to adapt to the plaque, covering any protrusion

Safety and efficacy of the new micromesh-covered stent CGuard™ in patients undergoing carotid artery stenting: early experience from a single centre

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Results: A single centre study, with 82 consecutive patients treated with CGuard™ in order to determine safety and efficacy of the micromesh covered CGuard™ compared to conventional stents that have plaque protrusion and represent the principal cause of cerebral embolization. Peri-operative technical and clinical success was met in 100% in symptomatic patients, and in 98.5% cases in asymptomatic patients. In the post-operative period (30 days), no new events were registered. The most recent 21 treated patients (24%) underwent DW-MRI in the peri-operative period.

Highlights

FU and Comments: CGuard™ was found to be safe and effective in both symptomatic and asymptomatic patients, independently of aortic arch anatomy. A subgroup was analysed with DWMRI and confirmed the neuro protection given with CGuard™ compared with historical series of conventional stents.

30-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard™ MicroNet™ covered embolic prevention stent system in real world multicentre clinical practice: the IRON-GUARD study

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200 patients in 12 centres were treated with CGuard™ EPS with a technical success of 100%. DW-MRI was used 72 hours prior to and after the procedure in several centres and a total elimination of post-procedural neurologic complications at 30 days was observed.

Highlights

This is the first “Real Life” vascular surgeons multicentric study. The procedural and clinical 30d FU were excellent. A subgroup was analysed with DWMRI and confirmed the neuro protection given with CGuard™ compared with historical series of conventional stents.

Clinical Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent

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A prospective study of 30 patients with symptomatic or high-grade stenosis of the ICA. Due to the CGuard™ flexibility and high radial force, it displayed excellent plaque coverage with “very safe implantation behavior”. 100% technical success was achieved in all patients and no MACE observed within the 6month follow up.

Highlights

In addition to the excellent CGuard™ clinical results, the unique value of Dr. Wissgott’s work was the analysis of the structural and mechanical stent properties, that demonstrated superiority in conformability and flexibility to other available mesh stents.

Double layered stents for carotid angioplasty: A meta-analysis of available clinical data

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Ten studies, enrolling 635 patients, were included in the present meta‐analysis. Several small sized clinical studies evaluating two different devices have been recently published, unfortunately these are not sufficiently powered to test for device related and clinical endpoints and no comparison, between the two available devices, has been reported yet. Our study analyzed a composite endpoint of 30‐day stroke and death and the occurrence of procedural unsuccess after CAS with the use of two different double layered carotid stent systems. The need for an increase plaque coverage to decrease the risk of debris dislodgement through the stent struts, following carotid artery stenting (CAS), has brought to the design of a new generation of double layered carotid stents.

Highlights

This meta‐analysis suggests that dual layered carotid stents could be safely used for the treatment of extracranial carotid artery stenosis, with a relatively low rate of procedural unsuccess, and allow achieving a quite low rate of postprocedural adverse events.

“Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard™ MicroNet™-covered embolic prevention stent system”

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CGuard™ PARADIGM Study101 consecutive all comer carotid stenosis patients.

Highlights

Device delivery success 99.1%, Periprocedural complications 0%, angiographic diameter stenosis or vessel narrowing reduced from 83±9% to 6.7±5% (p<0.001). No new events (0%) at 30 days.

Carotid Artery Revascularization for Stroke Prevention: A New Era

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A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: CARENET

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A prospective, multi-centre study with 30 patients to evaluate the CGuard™ EPS system in preventing embolic events to target lesions in patients suitable for carotid stenting.

Highlights

This study included pre and postprocedural DWMRI that displays the neuro protection given with CGuard™ compared with historical series of conventional stents. MACCE at 30-d were 0%. From the index procedure through 12 months no stroke or stroke-related death occurred, there were no adverse cardiac events, and no re-intervention was required. In-stent restenosis appeared in one case. No external carotid artery occlusion occurred at CAS or during the follow-up. Twelve-month clinical and duplex ultrasound data from the CARENET study are consistent with normal device healing and indicate safety and durability of CAS using the CGuard™ EPS.