Post Market Surveillance Study of the Wingspan Stent System
NCT ID: NCT02034058
Last Updated: 2019-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2013-12-31
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Wingspan Stent System
Placement of the Wingspan Stent
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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Stryker Neurovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Michael J Alexander, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Wengui Yu, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Locations
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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
Cadence Health, Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Massachusetts, Worcester
Worcester, Massachusetts, United States
St. John Hospital and Medical Center, Inc.
Detroit, Michigan, United States
SSM DePaul Health Center
Bridgeton, Missouri, United States
Columbia University Medical Center
New York, New York, United States
University Hospital of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Tennessee Interventional Associates
Chattanooga, Tennessee, United States
Valley Baptist Harlingen
Harlingen, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University of Washington, Harborview Medical Center
Seattle, Washington, United States
Multicare Medical Center
Tacoma, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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WEAVE Trial
Identifier Type: -
Identifier Source: org_study_id
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