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Trial record 2 of 8 for:    WINGSPAN

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Stryker Neurovascular
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT02034058
First received: January 9, 2014
Last updated: November 11, 2014
Last verified: November 2014
  Purpose

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 Intervention
Intracranial Atherosclerosis
Device: Wingspan Stent System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study

Resource links provided by NLM:


Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Stroke or Death [ Time Frame: within 72 hours of the procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ischemic Stroke [ Time Frame: within 72 hours post procedure ] [ Designated as safety issue: No ]
  • Neurological Death [ Time Frame: within 72 hours post procedure ] [ Designated as safety issue: Yes ]
  • Stroke recovery [ Time Frame: at 90 days post procedure ] [ Designated as safety issue: Yes ]
  • Stroke in the territory of the stented artery [ Time Frame: within 72 hours post procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 389
Study Start Date: December 2013
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034058

Contacts
Contact: Lisha Capucion 510-413-2584 Lisha.Capucion@Stryker.com
Contact: Lani Faulkner 510-413-2719 Lani.Faulkner@Stryker.com

  Show 25 Study Locations
Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Michael J Alexander, M.D. Cedars-Sinai Medical Center
Principal Investigator: Wengui Yu, M.D. Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02034058     History of Changes
Other Study ID Numbers: WEAVE Trial
Study First Received: January 9, 2014
Last Updated: November 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stryker Neurovascular:
Wingspan Stent System
Wingspan Stent
Intracranial Stent
Ischemic Stroke
Intracranial Atherosclerotic Disease
Intracranial Stenosis

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Intracranial Arteriosclerosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014