N/A
Completed N=82
An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis
Source: ClinicalTrials.gov NCT00929383 ↗Enrolled (actual)
82
Serious AEs
35.4%
Results posted
Jun 2014
Primary outcomePrimary: Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion) — 78 patients w stent implanted
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion) |
78 | — |
| PRIMARY Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death) |
12 | — |
| PRIMARY Rate of Recurrent Ischemic Stroke in the Target Territory |
1 | — |
| SECONDARY Cumulative Stroke Rate at 12 Months |
13 | — |
| SECONDARY Rate of Restenosis |
8 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00929383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.