Intracranial AtherosclerosisWEAVENCT02034058

Post Market Surveillance Study of the Wingspan Stent System

A study testing Wingspan Stent System in people with Intracranial Atherosclerosis, run by Stryker Neurovascular at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Intracranial Atherosclerosis
What is being tested?: Wingspan Stent System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 26 sitesUnited States
Study dates: Dec 2013to Aug 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

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

Other trials in United States

About this study

Official title: WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study

Read the 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.

Conditions: Intracranial Atherosclerosis
Being tested: Wingspan Stent System
Keywords: Wingspan Stent System, Wingspan Stent, Intracranial Stent, Ischemic Stroke, Intracranial Atherosclerotic Disease, Intracranial Stenosis
Medical subject headings: Intracranial Arteriosclerosis, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Wingspan Stent SystemDevice
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 groups in NCT02034058
Study group	Role	What they receive
Wingspan Stent System	Other	Placement of the Wingspan Stent Receives: Device: Wingspan Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: within 72 hours of the procedure

Secondary outcomes (4)

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.
Measured: within 72 hours post procedure
Rate of Neurological Death Among Participants
A diagnosis of death by neurological criteria
Measured: 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.
Measured: 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
Measured: within 72 hours post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Aug 2019

First posted13 Jan 2014 (estimated)
Study startDec 2013
Primary completionAug 2019
Study completionAug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Intracranial AtherosclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02034058
Sponsor's protocol ID: WEAVE Trial
Acronym: WEAVE
Status last verified: Nov 2019
First submitted: 9 Jan 2014
Last updated: 2 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 31125298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
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EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease
Intracranial Atherosclerosis, Intracranial Arterial Stenosis
RecruitingObservational study
BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease
Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis
Not yet recruiting
INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)

All Intracranial Atherosclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study
ClinicalTrials.gov ID: NCT02034058
Acronym / sponsor ID: WEAVE / WEAVE Trial
Conditions: Intracranial Atherosclerosis
Keywords: Wingspan Stent System, Wingspan Stent, Intracranial Stent, Ischemic Stroke, Intracranial Atherosclerotic Disease, Intracranial Stenosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Stryker NeurovascularIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Aug 2019 (actual)
Study completion: Aug 2019 (actual)
First posted: 13 Jan 2014 (estimated)
Results: Posted 2 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Wingspan Stent System	Other	Device: Wingspan Stent SystemPlacement of the Wingspan Stent

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Wingspan Stent SystemThe 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.	Device	Wingspan Stent System

Primary outcome

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.

4 secondary outcomes

Rate of Ischemic Stroke Among Participants
Time frame: within 72 hours post procedure
Rate of Neurological Death Among Participants
Time frame: within 72 hours post procedure
Rate of Stroke Recovery Among Participants
Time frame: at 90 days post procedure
Rate of Stroke in the Territory of the Stented Artery Among Participants
Time frame: within 72 hours post procedure

Results and safety

Results posted to the registry on 2 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stenting	152	149

Primary outcome: Rate of Stroke or Death Among Participants

Time frame: within 72 hours of the procedure. Count of participants. Unit: Participants

Measure	Stenting n = 152
Value	4

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stenting	9 of 152 (5.9%)	12 of 152 (7.9%)	3 of 152

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31125298Alexander 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.

Related trials for Intracranial Atherosclerosis

Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
Not yet recruiting
EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease
Intracranial Atherosclerosis, Intracranial Arterial Stenosis
RecruitingObservational study
BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease
Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis
Not yet recruiting
INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael J Alexander, M.D. principal investigator

Cedars-Sinai Medical Center

Wengui Yu, M.D. principal investigator

University of California, Irvine

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wingspan Stent System in people with Intracranial Atherosclerosis, run by Stryker Neurovascular at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Stroke or Death Among Participants (time frame: within 72 hours of the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02034058, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.