Post Market Surveillance Study of the Wingspan Stent System

NCT ID: NCT02034058

Last Updated: 2019-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2019-08-31

Brief Summary

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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

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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.

Conditions

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Intracranial Atherosclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Wingspan Stent System

Placement of the Wingspan Stent

Group Type OTHER

Wingspan Stent System

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

All patients for whom treatment with the Wingspan Stent System is considered.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Neurovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Sutter Eden Medical Center

Castro Valley, California, United States

Site Status

Southern California Permanente Medical Group

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

UCSD Medical Center

San Diego, California, United States

Site Status

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Emory University, Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

WellStar Health System

Marietta, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Cadence Health, Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

University of Kentucky Medical Center

Lexington, Kentucky, United States

Site Status

University of Massachusetts, Worcester

Worcester, Massachusetts, United States

Site Status

St. John Hospital and Medical Center, Inc.

Detroit, Michigan, United States

Site Status

SSM DePaul Health Center

Bridgeton, Missouri, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

University Hospital of Cincinnati

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Tennessee Interventional Associates

Chattanooga, Tennessee, United States

Site Status

Valley Baptist Harlingen

Harlingen, Texas, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

University of Washington, Harborview Medical Center

Seattle, Washington, United States

Site Status

Multicare Medical Center

Tacoma, Washington, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 31125298 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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WEAVE Trial

Identifier Type: -

Identifier Source: org_study_id

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