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A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis

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Published on: May 14, 2013

Independent Modular Filter for Embolic Protection in Carotid Stenting.

Dierk Scheinert¹, Bernhard Reimers¹, Alberto Cremonesi¹

¹From the Department of Interventional Angiology, Herzzentrum Leipzig GmbH and Park-Krankenhaus, Leipzig, Germany (D.S., A.S.); Department of Clinical and Invasive Cardiology, Humanitas Clinica and Research Center, Rozzano (Milan), Italy (B.R.); Department of Interventional Cardio-Angiology, Villa Maria Cecilia, Cotignola (RA), Italy (A.C.); Department Internal Medicine, Cardiology and Vascular Medicine, CardioVascular Center, Frankfurt, Germany (H.S.); Department of Radiology and Neuroradiology, Klinikum Dortmund, Dortmund, Germany (S.R.); Department of Cardiology, Hamburg University Cardiovascular Center, Hamburg, Germany (J.S.); Department of Cardiology, Klinikum Neuperlach, Munchen, Germany (H.G.M.); Department of Vascular Surgery, AZ Sint Blasius, Dendermonde, Belgium (M.B.); Department Angiology Internist, Universitats Herzzentrum, Bad Krozingen, Germany (T.Z.); Department of Cardiology, Mirano Hospital, Italy (A.P.); and Bnai Zion Medical Center, Technion-Israel Institute of Technology, Haifa, Israel (U.R.).

Circulation. Cardiovascular Interventions

|March 12, 2017

Summary

This summary is machine-generated.

The Wirion Embolic Protection System demonstrated a significantly lower rate of death, stroke, and myocardial infarction in patients undergoing carotid artery stenting compared to historical data.

Keywords:

carotid artery embolic protection embolic stroke myocardial infarction stenting

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Area of Science:

Cardiovascular Medicine
Interventional Cardiology
Medical Devices

Background:

Carotid artery stenting (CAS) is a procedure to open narrowed carotid arteries.
Thromboembolic events are a significant risk during CAS.
Embolic protection devices aim to reduce these complications.

Purpose of the Study:

To evaluate the safety and performance of the Wirion Embolic Protection System during CAS.
To assess the efficacy of the Wirion system in reducing adverse events in high-risk patients.

Main Methods:

Prospective, multicenter, nonrandomized, open-label, single-arm study (WISE study).
Interim analysis of the first 120 patients undergoing CAS with the Wirion system.
Primary endpoint: composite of death, stroke, and myocardial infarction at 30 days, compared to historical controls.

Main Results:

The primary endpoint occurred in 3.3% of patients with the Wirion system versus 6.3% in historical controls (P=0.0008).
Numerically lower rates of mortality (0% vs 1.7%), stroke (2.5% vs 4.6%), and myocardial infarction (0.8% vs 1.5%) were observed.
High rates of device, angiographic, procedural, and clinical success (99.2%, 99.1%, 98.3%, 96.6% respectively) were achieved.

Conclusions:

The Wirion Embolic Protection System is safe and effective for CAS in high surgical risk patients.
Use of this independent modular filter may reduce embolic complications during carotid stenting.