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

Stryker

Status: Completed

Conditions: Intracranial Atherosclerosis

Treatments: Device: Wingspan Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02034058

WEAVE Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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152 participants in 1 patient group

Wingspan Stent System

Other group

Description:

Placement of the Wingspan Stent

Treatment:

Device: Wingspan Stent System