NCT02034058

Post Market Surveillance Study of the Wingspan Stent System

WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Stryker Neurovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Atherosclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2014-01-13
• Last updated: 2019-12-02
• Results posted: 2019-12-02

Locations

26 sites across 1 country: United States