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WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study
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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
University of Alabama-Birmingham
Birmingham, Alabama, United States
Sutter Eden Medical Center
Castro Valley, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCSD Medical Center
San Diego, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Emory University, Grady Memorial Hospital
Atlanta, Georgia, United States
WellStar Health System
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Start Date
December 1, 2013
Primary Completion Date
August 1, 2019
Completion Date
August 1, 2019
Last Updated
December 2, 2019
152
ACTUAL participants
Wingspan Stent System
DEVICE
Lead Sponsor
Stryker Neurovascular
NCT05316311
NCT06902740
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04948749