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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.
 
ClinicalTrials.gov Identifier: NCT02034058
Recruitment Status : Completed
First Posted : January 13, 2014
Results First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: N/A
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
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 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. Rate of Stroke or Death Among Participants [ Time Frame: within 72 hours of the procedure ]
    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.


Secondary Outcome Measures :
  1. Rate of Ischemic Stroke Among Participants [ Time Frame: within 72 hours post procedure ]
    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.

  2. Rate of Neurological Death Among Participants [ Time Frame: within 72 hours post procedure ]
    A diagnosis of death by neurological criteria

  3. Rate of Stroke Recovery Among Participants [ Time Frame: at 90 days post procedure ]
    Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90.

  4. Rate of Stroke in the Territory of the Stented Artery Among Participants [ Time Frame: within 72 hours post procedure ]
    Stroke in the vascular territory of the stented artery



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
Criteria
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 ClinicalTrials.gov identifier (NCT number): NCT02034058


Locations
Show Show 26 study locations
Sponsors and Collaborators
Stryker Neurovascular
Investigators
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Principal Investigator: Michael J Alexander, M.D. Cedars-Sinai Medical Center
Principal Investigator: Wengui Yu, M.D. University of California, Irvine
  Study Documents (Full-Text)

Documents provided by Stryker Neurovascular:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02034058    
Other Study ID Numbers: WEAVE Trial
First Posted: January 13, 2014    Key Record Dates
Results First Posted: December 2, 2019
Last Update Posted: December 2, 2019
Last Verified: November 2019
Keywords provided by Stryker Neurovascular:
Wingspan Stent System
Wingspan Stent
Intracranial Stent
Ischemic Stroke
Intracranial Atherosclerotic Disease
Intracranial Stenosis
Additional relevant MeSH terms:
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Intracranial Arteriosclerosis
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases