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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

Tracking Information
First Submitted Date  ICMJE January 9, 2014
First Posted Date  ICMJE January 13, 2014
Results First Submitted Date  ICMJE October 10, 2019
Results First Posted Date  ICMJE December 2, 2019
Last Update Posted Date December 2, 2019
Study Start Date  ICMJE December 2013
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
Stroke or Death [ Time Frame: within 72 hours of the procedure ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
  • 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.
  • Rate of Neurological Death Among Participants [ Time Frame: within 72 hours post procedure ]
    A diagnosis of death by neurological criteria
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post Market Surveillance Study of the Wingspan Stent System
Official Title  ICMJE WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Intracranial Atherosclerosis
Intervention  ICMJE 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.
Study Arms  ICMJE Wingspan Stent System
Placement of the Wingspan Stent
Intervention: Device: Wingspan Stent System
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2019)
152
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2014)
389
Actual Study Completion Date  ICMJE August 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE All patients for whom treatment with the Wingspan Stent System is considered.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034058
Other Study ID Numbers  ICMJE WEAVE Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stryker Neurovascular
Study Sponsor  ICMJE Stryker Neurovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael J Alexander, M.D. Cedars-Sinai Medical Center
Principal Investigator: Wengui Yu, M.D. University of California, Irvine
PRS Account Stryker Neurovascular
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP