An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis

Completed

• Conditions: Intracranial Atherosclerosis

• Registration Number: NCT00929383
• Lead Sponsor: Stryker Neurovascular

Brief Summary

The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter in routine clinical practice.

Detailed Description

The Wingspan™ Stent System and Gateway™ PTA Balloon Catheter have CE mark and are commonly used in Europe. All the data collected in this registry will be from patients treated according to the physician's choice, per instructions for use, per approved indications and per local standard of care. The results from this registry will provide an understanding of the use and outcomes associated with the Wingspan™ Stent in a real world setting.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-06-26
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-29
• Status Verified: 2012-09
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-03-14
• Results First Submitted QC: 2014-05-15
• Last Update Submitted: 2014-05-15
• Results First Posted: 2014-06-17
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Symptomatic stenosis of one of those intracranial arteries: Internal carotid artery (ICA ), M1 segment of the MCA, V4 segment of vertebral artery, basilar artery
• A Modified Rankin Score of ≤ 3
• A target vessel diameter between 2mm and ≤ 4.5mm
• Length of the target lesion of ≤ 14 mm
• Patient older than 40 years old

Exclusion Criteria

• Patient previously stented at the target lesion
• Intracranial stenosis related to disease such as: arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy or fibromuscular dysplasia
• Complete occlusion of the artery on the imaging assessment
• Contraindications to antithrombotic and/or anticoagulant therapies
• Women who are pregnant or breast-feeding
• Patient not likely to be available for follow-up
• Patient protected by the law (safeguard of justice, supervision or trusteeship)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)	Peri-procedural	The number of Wingspan Stents successfully deployed across the target lesion.
Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)	30 days	Any stroke or neurological death at \</= 30 days will be included in the cumulative morbidity and mortality rate.; There was a 14.6% rate of cumulative morbidity and mortality at 30 days comprised of 12 events/82 patients.
Rate of Recurrent Ischemic Stroke in the Target Territory	12 Months	The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.

Secondary Outcome Measures

Name	Time	Method
Cumulative Stroke Rate at 12 Months	12 months	The cumulative stroke rate at 12 months (any stroke or neurological death \</= 30 days or any ischemic stroke in territory \>/= 31 days is 15.9% or 13 events per 82 patients
Rate of Restenosis	12 Months	The rate of restenosis at 12 months was defined as the degree of residual stenosis greater than 50% as determined by the study sites using the WASID method. There was a 10.4% rate of restenosis \>50% or 8 patients out of 77 analyzed. The differences in this analysis population N=77 vs. ITT N= 82 populations results from exclusion of N=4 patients with no stent implanted and N=1 patient who died prior to any follow up measures of restenosis.; The WASID method is a standardized protocol for measuring intracranial arterial stenosis.; \[1-(Dstenosis/Dnormal)\] x100=% stenosis (where D=vessel diameter)

Trial Locations

Locations (19)

CHU Reims; 🇫🇷 Reims, France

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Hôpital Saint-Roch; 🇫🇷 Nice, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

CHU Dijon-Hopital General; 🇫🇷 Dijon, France

CHU Limoges; 🇫🇷 Limoges, France

Höpital Gui de Chauliac; 🇫🇷 Montpellier, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Hôpital Guillaume et René Laënnec; 🇫🇷 Nantes, France

Fondation Rotschild; 🇫🇷 Paris, France

Universitätsklinikum Dresden; 🇩🇪 Dresden, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

UKSH Campus Kiel; 🇩🇪 Kiel, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany