Clinical trial NCT02034058: Post Market Surveillance Study of the Wingspan Stent System
Official title: WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Atherosclerosis
Keywords: Wingspan Stent System
Wingspan Stent
Intracranial Stent
Ischemic Stroke
Intracranial Atherosclerotic Disease
Intracranial Stenosis
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of Stroke or Death Among Participants
timeFrame: within 72 hours of the procedure
Secondary outcomes:
measure: Rate of Ischemic Stroke Among Participants
timeFrame: within 72 hours post procedure
measure: Rate of Neurological Death Among Participants
timeFrame: within 72 hours post procedure
measure: Rate of Stroke Recovery Among Participants
timeFrame: at 90 days post procedure
measure: Rate of Stroke in the Territory of the Stented Artery Among Participants
timeFrame: within 72 hours post procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: Castro Valley
country: United States
facility: Sutter Eden Medical Center
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Atlanta
country: United States
facility: Emory University, Grady Memorial Hospital
state: Georgia
city: Marietta
country: United States
facility: WellStar Health System
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Winfield
country: United States
facility: Cadence Health, Northwestern Medicine Central DuPage Hospital
state: Illinois
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Worcester
country: United States
facility: University of Massachusetts, Worcester
state: Massachusetts
city: Detroit
country: United States
facility: St. John Hospital and Medical Center, Inc.
state: Michigan
city: Bridgeton
country: United States
facility: SSM DePaul Health Center
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: University Hospital of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Tennessee Interventional Associates
state: Tennessee
city: Harlingen
country: United States
facility: Valley Baptist Harlingen
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington, Harborview Medical Center
state: Washington
city: Tacoma
country: United States
facility: Multicare Medical Center
state: Washington
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Michael J Alexander, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Wengui Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.