Post Market Surveillance Study of the Wingspan Stent System (WEAVE)
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|ClinicalTrials.gov Identifier: NCT02034058|
Recruitment Status : Completed
First Posted : January 13, 2014
Results First Posted : December 2, 2019
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Atherosclerosis||Device: Wingspan Stent System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||August 2019|
Wingspan Stent System
Placement of the Wingspan Stent
Device: Wingspan Stent System
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.
- Rate of Stroke or Death Among Participants [ Time Frame: within 72 hours of the procedure ]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.
- Rate of Ischemic Stroke Among Participants [ Time Frame: within 72 hours post procedure ]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.
- Rate of Neurological Death Among Participants [ Time Frame: within 72 hours post procedure ]A diagnosis of death by neurological criteria
- Rate of Stroke Recovery Among Participants [ Time Frame: at 90 days post procedure ]Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90.
- Rate of Stroke in the Territory of the Stented Artery Among Participants [ Time Frame: within 72 hours post procedure ]Stroke in the vascular territory of the stented artery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034058
|Principal Investigator:||Michael J Alexander, M.D.||Cedars-Sinai Medical Center|
|Principal Investigator:||Wengui Yu, M.D.||University of California, Irvine|