Clinical Trial: Post Market Surveillance Study of the Wingspan Stent System
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study
Brief Summary: 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 Summary: 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.
Sponsor: Stryker Neurovascular
Current Primary Outcome: Stroke or Death [ Time Frame: within 72 hours of the procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Ischemic Stroke [ Time Frame: within 72 hours post procedure ]
- Neurological Death [ Time Frame: within 72 hours post procedure ]
- Stroke recovery [ Time Frame: at 90 days post procedure ]
- Stroke in the territory of the stented artery [ Time Frame: within 72 hours post procedure ]
Original Secondary Outcome: Same as current
Information By: Stryker Neurovascular
Dates:
Date Received: January 9, 2014
Date Started: December 2013
Date Completion: July 2019
Last Updated: May 4, 2016
Last Verified: May 2016
