Post Market Surveillance Study of the Wingspan Stent System (WEAVE)
Primary Purpose
Intracranial Atherosclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wingspan Stent System
Sponsored by
About this trial
This is an interventional prevention trial for Intracranial Atherosclerosis focused on measuring Wingspan Stent System, Wingspan Stent, Intracranial Stent, Ischemic Stroke, Intracranial Atherosclerotic Disease, Intracranial Stenosis
Eligibility Criteria
All patients for whom treatment with the Wingspan Stent System is considered.
Sites / Locations
- University of Alabama-Birmingham
- Sutter Eden Medical Center
- Southern California Permanente Medical Group
- Cedars-Sinai Medical Center
- UCSD Medical Center
- Santa Barbara Cottage Hospital
- Mount Sinai Medical Center
- Emory University, Grady Memorial Hospital
- WellStar Health System
- University of Chicago
- Cadence Health, Northwestern Medicine Central DuPage Hospital
- Baptist Health Lexington
- University of Kentucky Medical Center
- University of Massachusetts, Worcester
- St. John Hospital and Medical Center, Inc.
- SSM DePaul Health Center
- Columbia University Medical Center
- University Hospital of Cincinnati
- Cleveland Clinic
- Oregon Health & Science University
- Abington Memorial Hospital
- Tennessee Interventional Associates
- Valley Baptist Harlingen
- Sentara Norfolk General Hospital
- University of Washington, Harborview Medical Center
- Multicare Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Wingspan Stent System
Arm Description
Placement of the Wingspan Stent
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of Ischemic Stroke Among Participants
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.
Rate of Neurological Death Among Participants
A diagnosis of death by neurological criteria
Rate of Stroke Recovery Among Participants
Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90.
Rate of Stroke in the Territory of the Stented Artery Among Participants
Stroke in the vascular territory of the stented artery
Full Information
NCT ID
NCT02034058
First Posted
January 9, 2014
Last Updated
November 27, 2019
Sponsor
Stryker Neurovascular
1. Study Identification
Unique Protocol Identification Number
NCT02034058
Brief Title
Post Market Surveillance Study of the Wingspan Stent System
Acronym
WEAVE
Official Title
WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Neurovascular
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Atherosclerosis
Keywords
Wingspan Stent System, Wingspan Stent, Intracranial Stent, Ischemic Stroke, Intracranial Atherosclerotic Disease, Intracranial Stenosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wingspan Stent System
Arm Type
Other
Arm Description
Placement of the Wingspan Stent
Intervention Type
Device
Intervention Name(s)
Wingspan Stent System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Stroke or Death Among Participants
Description
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.
Time Frame
within 72 hours of the procedure
Secondary Outcome Measure Information:
Title
Rate of Ischemic Stroke Among Participants
Description
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.
Time Frame
within 72 hours post procedure
Title
Rate of Neurological Death Among Participants
Description
A diagnosis of death by neurological criteria
Time Frame
within 72 hours post procedure
Title
Rate of Stroke Recovery Among Participants
Description
Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90.
Time Frame
at 90 days post procedure
Title
Rate of Stroke in the Territory of the Stented Artery Among Participants
Description
Stroke in the vascular territory of the stented artery
Time Frame
within 72 hours post procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
All patients for whom treatment with the Wingspan Stent System is considered.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Alexander, M.D.
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wengui Yu, M.D.
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Sutter Eden Medical Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Emory University, Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
WellStar Health System
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Cadence Health, Northwestern Medicine Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Massachusetts, Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
St. John Hospital and Medical Center, Inc.
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
SSM DePaul Health Center
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University Hospital of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Tennessee Interventional Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Valley Baptist Harlingen
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
University of Washington, Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Multicare Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31125298
Citation
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.
Results Reference
derived
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Post Market Surveillance Study of the Wingspan Stent System
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