Post Market Surveillance Study of the Wingspan Stent System
WEAVE
WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study
1 other identifier
interventional
152
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedResults Posted
Study results publicly available
December 2, 2019
CompletedDecember 2, 2019
November 1, 2019
5.7 years
January 9, 2014
October 10, 2019
November 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Rate of Ischemic Stroke Among Participants
within 72 hours post procedure
Rate of Neurological Death Among Participants
within 72 hours post procedure
Rate of Stroke Recovery Among Participants
at 90 days post procedure
Rate of Stroke in the Territory of the Stented Artery Among Participants
within 72 hours post procedure
Study Arms (1)
Wingspan Stent System
OTHERPlacement of the Wingspan Stent
Interventions
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.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (26)
University of Alabama-Birmingham
Birmingham, Alabama, 35294, United States
Sutter Eden Medical Center
Castro Valley, California, 94546, United States
Southern California Permanente Medical Group
Los Angeles, California, 90027, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UCSD Medical Center
San Diego, California, 92103, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Emory University, Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
WellStar Health System
Marietta, Georgia, 30060, United States
University of Chicago
Chicago, Illinois, 60637, United States
Cadence Health, Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
University of Massachusetts, Worcester
Worcester, Massachusetts, 01655, United States
St. John Hospital and Medical Center, Inc.
Detroit, Michigan, 48236, United States
SSM DePaul Health Center
Bridgeton, Missouri, 63044, United States
Columbia University Medical Center
New York, New York, 10032, United States
University Hospital of Cincinnati
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97219, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Tennessee Interventional Associates
Chattanooga, Tennessee, 37403, United States
Valley Baptist Harlingen
Harlingen, Texas, 78550, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
University of Washington, Harborview Medical Center
Seattle, Washington, 98104, United States
Multicare Medical Center
Tacoma, Washington, 98405, United States
Related Publications (1)
Alexander MJ, Zauner A, Chaloupka JC, Baxter B, Callison RC, Gupta R, Song SS, Yu W; WEAVE Trial Sites and Interventionalists. WEAVE Trial: Final Results in 152 On-Label Patients. Stroke. 2019 Apr;50(4):889-894. doi: 10.1161/STROKEAHA.118.023996.
PMID: 31125298DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alice Lin, Clinical Program Manager
- Organization
- Stryker Neurovascular
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Alexander, M.D.
Cedars-Sinai Medical Center
- PRINCIPAL INVESTIGATOR
Wengui Yu, M.D.
University of California, Irvine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2014
First Posted
January 13, 2014
Study Start
December 1, 2013
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
December 2, 2019
Results First Posted
December 2, 2019
Record last verified: 2019-11