Status:
COMPLETED
An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis
Lead Sponsor:
Stryker Neurovascular
Conditions:
Intracranial Atherosclerosis
Eligibility:
All Genders
41+ years
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...
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 physic...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00929383
Start Date
February 1 2009
End Date
March 1 2013
Last Update
June 17 2014
Active Locations (19)
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1
Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
2
CHU Dijon-Hopital General
Dijon, France, 21033
3
CHU Limoges
Limoges, France, 87042
4
Höpital Gui de Chauliac
Montpellier, France, 34059