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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intracranial Atherosclerosis

Intervention / Treatment
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* Device: Wingspan Stent System with Gateway PTA Balloon Catheter


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Wingspan Stent System with Gateway PTA Balloon Catheter|The Wingspan Stent System is used in conjunction with Gateway PTA Balloon Catheter to improve cerebral artery lumen diameter in patients with intracranial atherosclerotic disease. The Gateway Balloon Catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries prior to stenting the artery for the purpose of improving intracranial perfusion.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion) | The number of Wingspan Stents successfully deployed across the target lesion. | Peri-procedural | 
| Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death) | 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. | 30 days | 
| Rate of Recurrent Ischemic Stroke in the Target Territory | The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Stroke Rate at 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 | 12 months | 
| Rate of Restenosis | 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) | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Atherosclerosis, Stenosis, ICAD, atherosclerotic lesions, stenting