CompletedNot Applicable

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

France, Germany82 participantsStarted 2009-02

Plain-language 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.

Who can participate

Age range

41 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)

Timeframe: Peri-procedural

Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)

Timeframe: 30 days

Rate of Recurrent Ischemic Stroke in the Target Territory

Timeframe: 12 Months

Trial details

NCT IDNCT00929383

SponsorStryker Neurovascular

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-03

Results submitted2014-03-14

View on ClinicalTrials.gov More Intracranial Atherosclerosis trials