Post Market Surveillance Study of the Wingspan Stent System (WEAVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02034058
Recruitment Status : Active, not recruiting
First Posted : January 13, 2014
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Stryker Neurovascular

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.

Condition or disease Intervention/treatment Phase
Intracranial Atherosclerosis Device: Wingspan Stent System Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 389 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study
Study Start Date : December 2013
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Wingspan Stent System
Placement of the Wingspan Stent
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.

Primary Outcome Measures :
  1. Stroke or Death [ Time Frame: within 72 hours of the procedure ]

Secondary Outcome Measures :
  1. Ischemic Stroke [ Time Frame: within 72 hours post procedure ]
  2. Neurological Death [ Time Frame: within 72 hours post procedure ]
  3. Stroke recovery [ Time Frame: at 90 days post procedure ]
  4. Stroke in the territory of the stented artery [ Time Frame: within 72 hours post procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
All patients for whom treatment with the Wingspan Stent System is considered.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02034058

  Show 26 Study Locations
Sponsors and Collaborators
Stryker Neurovascular
Principal Investigator: Michael J Alexander, M.D. Cedars-Sinai Medical Center
Principal Investigator: Wengui Yu, M.D. University of California, Irvine

Responsible Party: Stryker Neurovascular Identifier: NCT02034058     History of Changes
Other Study ID Numbers: WEAVE Trial
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Keywords provided by Stryker Neurovascular:
Wingspan Stent System
Wingspan Stent
Intracranial Stent
Ischemic Stroke
Intracranial Atherosclerotic Disease
Intracranial Stenosis

Additional relevant MeSH terms:
Intracranial Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases