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

WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Atherosclerosis
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama-Birmingham
  • California
    • Castro Valley, California, United States, 94546
      • Sutter Eden Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90027
      • Southern California Permanente Medical Group
    • San Diego, California, United States, 92103
      • UCSD Medical Center
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University, Grady Memorial Hospital
    • Marietta, Georgia, United States, 30060
      • Wellstar Health System
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Winfield, Illinois, United States, 60190
      • Cadence Health, Northwestern Medicine Central DuPage Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts, Worcester
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital and Medical Center, Inc.
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • SSM DePaul Health Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University Hospital of Cincinnati
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97219
      • Oregon Health & Science University
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Tennessee Interventional Associates
  • Texas
    • Harlingen, Texas, United States, 78550
      • Valley Baptist Harlingen
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington, Harborview Medical Center
    • Tacoma, Washington, United States, 98405
      • MultiCare Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Stroke or Death Among Participants	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.	within 72 hours of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Ischemic Stroke Among Participants	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.	within 72 hours post procedure
Rate of Neurological Death Among Participants	A diagnosis of death by neurological criteria	within 72 hours post procedure
Rate of Stroke Recovery Among Participants	Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90.	at 90 days post procedure
Rate of Stroke in the Territory of the Stented Artery Among Participants	Stroke in the vascular territory of the stented artery	within 72 hours post procedure

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: Michael J Alexander, M.D., Cedars-Sinai Medical Center; Principal Investigator: Wengui Yu, M.D., University of California, Irvine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (ESTIMATE): January 13, 2014

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Intracranial Stenosis; Wingspan Stent System; Wingspan Stent; Intracranial Stent; Intracranial Atherosclerotic Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Atherosclerosis; Intracranial Arteriosclerosis
• Other Study ID Numbers: WEAVE Trial