Post Market Surveillance Study of the Wingspan Stent System

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the rate of stroke and/or death in patients treated with the Wingspan Stent System, according to the Indications for Use, within 72 hours post procedure.

Detailed Description
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This research study is a Food and Drug Administration (FDA) mandated post market surveillance study of the Wingspan® Stent System, also known as the WEAVE™ Trial. The purpose of this trial is to fulfill a FDA requirement to evaluate the rate of stroke and/or death within 72 hours of the procedure, in patients who have a Wingspan Stent implanted in accordance with the Indications for Use.

Official Title
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WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study

Conditions
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Intracranial Atherosclerosis

Intervention / Treatment
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* Device: Wingspan Stent System


Participation Criteria
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Eligibility Criteria
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All patients for whom treatment with the Wingspan Stent System is considered.
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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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wingspan Stent System<br>Placement of the Wingspan Stent | Device: Wingspan Stent System<br>* The Wingspan Stent System is used with the Gateway PTA Balloon Catheter. The Wingspan Stent System is a self-expanding, Nitinol stent and delivery system intended for use in the treatment of intracranial atherosclerotic disease. The Gateway PTA Balloon Catheter is an over-the-wire balloon catheter intended for the pre-dilation of the lesion prior to insertion and deployment of the Wingspan Stent System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Stroke or Death Among Participants | The primary endpoint in this study is the rate of stroke (ischemic or hemorrhagic) or death within 72 hours of the procedure. Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic cause and is detectable on examination at least 24 hours after onset of symptoms. Hemorrhagic stroke was defined as a symptomatic intracerebral, subarachnoid, or primary intraventricular hemorrhage. The type of stroke was confirmed by imaging. | within 72 hours of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Ischemic Stroke Among Participants | Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic etiology and is detectable on examination at least 24 hours after onset of symptoms. | within 72 hours post procedure | 
| Rate of Neurological Death Among Participants | A diagnosis of death by neurological criteria | within 72 hours post procedure | 
| Rate of Stroke Recovery Among Participants | Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90. | at 90 days post procedure | 
| Rate of Stroke in the Territory of the Stented Artery Among Participants | Stroke in the vascular territory of the stented artery | within 72 hours post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wingspan Stent System, Wingspan Stent, Intracranial Stent, Ischemic Stroke, Intracranial Atherosclerotic Disease, Intracranial Stenosis