Post Market Surveillance Study of the Wingspan Stent System

N/ACompletedNCT02034058

Stryker Neurovascular152 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

152

Conditions

Intracranial Atherosclerosis

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (26)

Outcomes

Primary Outcomes

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.

Time frame: within 72 hours of the procedure

Secondary Outcomes

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.

Time frame: within 72 hours post procedure

Rate of Neurological Death Among Participants

A diagnosis of death by neurological criteria

Time frame: 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.

Time frame: 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

Time frame: within 72 hours post procedure

Data from ClinicalTrials.gov

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