An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis (IRISS)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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)
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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