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

This study is currently recruiting participants.
Verified June 2017 by Stryker Neurovascular
Sponsor:
ClinicalTrials.gov Identifier:
NCT02034058
First Posted: January 13, 2014
Last Update Posted: June 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stryker Neurovascular
  Purpose
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 Intervention
Intracranial Atherosclerosis Device: Wingspan Stent System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study

Further study details as provided by Stryker Neurovascular:

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

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

Estimated Enrollment: 389
Study Start Date: December 2013
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
All patients for whom treatment with the Wingspan Stent System is considered.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02034058


Contacts
Contact: David Hess 510-413-2642 David.Hess@Stryker.com
Contact: Lisha Capucion 510-413-2584 Lisha.Capucion@Stryker.com

  Show 27 Study Locations
Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Michael J Alexander, M.D. Cedars-Sinai Medical Center
Principal Investigator: Wengui Yu, M.D. University of California, Irvine
  More Information

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02034058     History of Changes
Other Study ID Numbers: WEAVE Trial
First Submitted: January 9, 2014
First Posted: January 13, 2014
Last Update Posted: June 21, 2017
Last Verified: June 2017

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

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


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