Post Market Surveillance Study of the Wingspan Stent System

Intracranial Atherosclerosis Clinical Trial

— WEAVE  

Official title:

WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034058
• Other study ID #: WEAVE Trial
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis

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