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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02034058
Other study ID # WEAVE Trial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date August 2019

Study information

Verified date November 2019
Source Stryker Neurovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility All patients for whom treatment with the Wingspan Stent System is considered.

Study Design


Intervention

Device:
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.

Locations

Country Name City State
United States Abington Memorial Hospital Abington Pennsylvania
United States Emory University, Grady Memorial Hospital Atlanta Georgia
United States University of Alabama-Birmingham Birmingham Alabama
United States SSM DePaul Health Center Bridgeton Missouri
United States Sutter Eden Medical Center Castro Valley California
United States Tennessee Interventional Associates Chattanooga Tennessee
United States University of Chicago Chicago Illinois
United States University Hospital of Cincinnati Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States St. John Hospital and Medical Center, Inc. Detroit Michigan
United States Valley Baptist Harlingen Harlingen Texas
United States Baptist Health Lexington Lexington Kentucky
United States University of Kentucky Medical Center Lexington Kentucky
United States Cedars-Sinai Medical Center Los Angeles California
United States Southern California Permanente Medical Group Los Angeles California
United States WellStar Health System Marietta Georgia
United States Mount Sinai Medical Center Miami Beach Florida
United States Columbia University Medical Center New York New York
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Oregon Health & Science University Portland Oregon
United States UCSD Medical Center San Diego California
United States Santa Barbara Cottage Hospital Santa Barbara California
United States University of Washington, Harborview Medical Center Seattle Washington
United States Multicare Medical Center Tacoma Washington
United States Cadence Health, Northwestern Medicine Central DuPage Hospital Winfield Illinois
United States University of Massachusetts, Worcester Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Stryker Neurovascular

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. within 72 hours post procedure
Secondary Rate of Neurological Death Among Participants A diagnosis of death by neurological criteria within 72 hours post procedure
Secondary Rate of Stroke Recovery Among Participants Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90. at 90 days post procedure
Secondary Rate of Stroke in the Territory of the Stented Artery Among Participants Stroke in the vascular territory of the stented artery within 72 hours post procedure
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