WEAVE Trial

Condition/Intervention:

  • Stroke

Study Name:

WEAVE Trial: Wingspan Stent System Post Market Surveillance Study

Phase:

Phase 4

Summary:

The purpose of this study is to fulfill a U.S. Food and Drug Administration requirement to collect information on the use of the Wingspan® Stent System with the Gateway® Percutaneous Transluminal Angioplasty Balloon Catheter, which has been approved as a Humanitarian Use Device. The device may allow a narrowed artery to become more open, thus permitting greater blood flow through the artery and to the brain.

Participants in this study will have had two or more strokes and have chosen to receive treatment with the Wingspan Stent System and Gateway PTA Balloon Catheter as part of their standard of care. The information collected will include the results of the procedure to better understand the benefits and risks of the Wingspan System.

Financial disclosure: Dr. Alexander receives compensation from the company sponsoring this study. This includes consulting fees and fees for speaking engagements.

Inclusion Criteria:

  • Patients who have a Wingspan stent procedure attempted
  • Provides informed consent
  • Age 22 – 80 years

Exclusion Criteria:

  • Pregnant women
  • Children

Principal Investigator:

Michael Alexander, MD

Co-Investigator:

Paula Eboli, MD

Study Coordinator and Contact:

Vicki Manoukian
Phone: 310-423-5067
Email: vicki.manoukian@cshs.org

Status:

Active

IRB No.:

33256

More information

Date Last Updated:

05/15