Post Market Surveillance Study of the Wingspan Stent System (WEAVE)
November 27, 2019 updated by: Stryker Neurovascular
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama-Birmingham
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California
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Castro Valley, California, United States, 94546
- Sutter Eden Medical Center
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, United States, 90027
- Southern California Permanente Medical Group
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San Diego, California, United States, 92103
- UCSD Medical Center
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Santa Barbara, California, United States, 93105
- Santa Barbara Cottage Hospital
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Florida
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Miami Beach, Florida, United States, 33140
- Mount Sinai Medical Center
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University, Grady Memorial Hospital
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Marietta, Georgia, United States, 30060
- Wellstar Health System
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Winfield, Illinois, United States, 60190
- Cadence Health, Northwestern Medicine Central DuPage Hospital
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky Medical Center
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Lexington, Kentucky, United States, 40503
- Baptist Health Lexington
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts, Worcester
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Michigan
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Detroit, Michigan, United States, 48236
- St. John Hospital and Medical Center, Inc.
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Missouri
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Bridgeton, Missouri, United States, 63044
- SSM DePaul Health Center
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- University Hospital of Cincinnati
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Oregon
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Portland, Oregon, United States, 97219
- Oregon Health & Science University
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Abington Memorial Hospital
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- Tennessee Interventional Associates
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Texas
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Harlingen, Texas, United States, 78550
- Valley Baptist Harlingen
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Virginia
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Norfolk, Virginia, United States, 23507
- Sentara Norfolk General Hospital
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Washington
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Seattle, Washington, United States, 98104
- University of Washington, Harborview Medical Center
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Tacoma, Washington, United States, 98405
- MultiCare Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
All patients for whom treatment with the Wingspan Stent System is considered.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Wingspan Stent System
Placement of the Wingspan Stent
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Stroke or Death Among Participants
Time Frame: within 72 hours of the procedure
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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.
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within 72 hours of the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Ischemic Stroke Among Participants
Time Frame: within 72 hours post procedure
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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.
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within 72 hours post procedure
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Rate of Neurological Death Among Participants
Time Frame: within 72 hours post procedure
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A diagnosis of death by neurological criteria
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within 72 hours post procedure
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Rate of Stroke Recovery Among Participants
Time Frame: at 90 days post procedure
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Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90.
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at 90 days post procedure
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Rate of Stroke in the Territory of the Stented Artery Among Participants
Time Frame: within 72 hours post procedure
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Stroke in the vascular territory of the stented artery
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within 72 hours post procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael J Alexander, M.D., Cedars-Sinai Medical Center
- Principal Investigator: Wengui Yu, M.D., University of California, Irvine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (ACTUAL)
August 1, 2019
Study Completion (ACTUAL)
August 1, 2019
Study Registration Dates
First Submitted
January 9, 2014
First Submitted That Met QC Criteria
January 9, 2014
First Posted (ESTIMATE)
January 13, 2014
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2019
Last Update Submitted That Met QC Criteria
November 27, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WEAVE Trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.