Publications

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.

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.

“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.

“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.