Publications

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

Publication

Advances in Interventional Cardiology 2020; 16, 4 (62): 495–506

Author

Mariusz Trystuła, Piotr Musiałek

Focus

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

Publication

JACC: Cardiovascular Interventions Volume 13, Issue 18, September 2020

Author

Pasqualino Sirignano; Eugenio Stabile; Wassim Mansour; Laura Capoccia; Federico Faccenna; Francesco Intrieri; Michelangelo Ferri; Salvatore Saccà; Massimo Sponza; Paolo Mortola; Sonia Ronchey; Placido Grillo; Roberto Chiappa; Sergio Losa; Francesco Setacci; Stefano Pirrelli; Maurizio Taurino; Maria Antonella Ruffino; Marco Udini; Domenico Palombo; Arnaldo Ippoliti; Nunzio Montelione; Carlo Setacci; Gianmarco de Donato; Massimo Ruggeri and Francesco Speziale

Focus

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

Publication

JACC: Cardiovascular Interventions Volume 13, Issue 14, 27 July 2020, Pages 1709-1715

Author

Eugenio Stabile MD, PhD; Gianmarco de Donato MD, PhD; Piotr Musialek MD, PhD; Koen Deloose MD; Roberto Nerla MD; Pasqualino Sirignano MD; Adam Mazurek MD; Wassim Mansour MD; Vincenzo Fioretti MD; Fabrizio Esposito MD; Salvatore Chianese MD; Marc Bosiers MD; Carlo Setacci MD; Francesco Speziale MD; Antonio Micari MD; Giovanni Esposito MD, PhD

Focus

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.

Publication

Eurointervention, June 2nd, 2020

Author

Adam Mazurek, M.D; Anna Borratynska, M.D, PhD; Krzysztof P. Malinowski, MSc; Mateusz Brozda, M.D; Urszula Gancarczyk, M.D; Natalia Dluzniewska, M.D; Łukasz Czyż, M.D; Martyna Duplicka, M.D; Ewa Sobieraj, M.D; Mariusz Trystula, M.D, PhD; Tomasz Drazkiewicz, M.D, PhD; Piotr Podolec, M.D, PhD; Piotr Musialek, M.D, DPhil

Focus

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

Publication

Journal of Vascular Surgery

Author

Pasqualino Sirignano MD, Wassim Mansour MD, PhD Laura Capoccia MD, PhD, Francesco Intrieri MD, Michelangelo Ferri MD, Salvatore Saccà MD, Massimo Sponza MD, Paolo Mortola MD, Eugenio Stabile MD, PhD Francesco Speziale MD

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

Publication

Catheter Cardiovasc Interv. 2019;1-8

Author

Adam Mazurek MD, Lukasz Partyka MD, PhD, Mariusz Trystula MD, PhD, Jacek Jakala MD, PhD, Klaudia Proniewska MSc, PhD, Anna Borratynska MD, PhD, Tomasz Tomaszewski MD, Magdalena Slezak MSc, Krzysztof P. Malinowski MSc, Tomasz Drazkiewicz MD, PhD, Piotr Podolec MD, PhD, Kenneth Rosenfiled MD, Piotr Musialek MD, DPhil

Focus

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

Publication

Journal of Endovascular Therapy 1–5 The Author(s) 2019

Author

Christian Wissgott, MD, Christoph Brandt-Wunderlich, PhD, Christoph Kopetsch, MD, Wolfram Schmidt, PhD, and Reimer Andresen, MD

Focus

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?

Publication

EuroIntervention 2018; 13: 1629-1630

Author

Alberto Cremonesi, MD, PhD; Roberto Nerla, MD; Fausto Castriota, MD

Focus

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 train-
ing are crucial, both in patient/lesion selection and in appropri-
ate 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 per-
formed by experienced and trained operators tailoring their strat-
egy 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

Publication

EuroIntervention 2018;14: 1150-1152

Author

Laura Capoccia, MD; Pasqualino Sirignano, MD; Wassim Mansour, MD; Enrico Sbarigia, MD; Francesco Speziale, MD

Focus

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

Publication

Seminars in Vascular Surgery Volume 31, Issue 1, March 2018, Pages 15-20

Author

Gianmarco de Donato, Francesco Setacci, Edoardo Pasqui, Domenico Benevento, Giancarlo Palasciano, Antonio Sterpetti, Luca di Marzo, CarloSetacci

Focus

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

Publication

JACC: Cardiovascular Interventions Volume 11, Issue 23, 10 December 2018, Pages 2405-2411

Author

Eugenio Stabile MD, PhD, Gianmarco de DonatoMD, PhD, PiotrMusialek MD, PhD cKoen De Loose MD, Roberto Nerla MD, Pasqualino Sirignano MD, Salvatore Chianese MD, Adam Mazurek MD, Tullio Tesorio MD, Marc Bosiers MD, Carlo Setacci MD, Francesco SpezialeMD, Antonio MicariMD, Giovanni EspositoMD, PhD

Focus

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”

Publication

Advances in Interventional Cardiology

Author

Professors Piotr Musialek, L. Nelson Hopkins, Adnan H. Siddiqui

Focus

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?

Publication

Seminars in Vascular Surgery Volume 30, Issue 1, March 2017, Pages 25-30

Author

Carly N. Richards, and Peter A. Schneider

Focus

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

Publication

Musialek, P, Kolvenbach, R, Schofer, J

Author

Musialek, P, Kolvenbach, R, Schofer, J

Focus

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?

Publication

EuroIntervention 2017;13:1266-1268

Author

Piotr Musialek MD, DPhil; Eugenio Stabile, MD, PhD

Focus

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 edge9 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

Publication

Eur J Vasc Endovasc Surg 2017 Dec. 54:688. 10.1016/j.ejvs.2017.10.006 R. Casana,

Author

R. Casana, V Tolva, A Odero Jr, C Malloggi, A Paolucci, F Triulzi, V. Silani

Focus

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

Publication

Ref: EuroIntervention 2017 05 09. 10.4244/EIJ-D-17-00008

Author

Francesco Speziale, MD; Laura Capoccia, MD; Pasqualino Sirignamo, MD; Wassim Mansour, MD; Chiara Pranteda, MD; Renato Casana, MD; Carlo Setacci, MD.

Focus

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

Publication

J Endovasc Ther 2017 02. 24:130-137.

Author

Christian Wissgott, MD1, Wolfram Schmidt, PhD2, Christoph Brandt-Wunderlich, MSc2, Peter Behrens, MSc2, and Reimer Andresen, MD

Focus

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

Publication

Catheter Cardiovasc Interv. 2017;1–7

Author

Anna Sannino, MD, Giuseppe Giugliano, MD, PhD, Evelina Toscano, MD Gabriele G. Schiattarella, MD Anna Franzone, MD, PhD Tullio Tesorio, MD Bruno Trimarco, MD Giovanni Esposito, MD, PhD Eugenio Stabile, MD, PhD

Focus

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”

Publication

EuroIntervention 2016 Aug 05. 658-70.

Author

Piotr Musialek et al.

Focus

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

Publication

Journal of Endovascular Therapy 1-11

Author

Piotr Musialek MD, DPhil, Silke Hopf-Jensen, MD

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

Publication

JACC Cardiovasc Interv 2015 Aug 17. 8:1229-1234

Author

Joachim Schofer, MD,* Piotr Musiałek, MD, DPHIL,y Klaudija Bijuklic, MD,* Ralf Kolvenbach, MD,z Mariusz Trystula, MD,y Zbigniew Siudak, MD,yx Horst Sievert, MDk

Focus

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.