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Post Market Surveillance Study of the Wingspan Stent System

NCT02034058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2019-12-02

Study results available
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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.

Conditions

  • Intracranial Atherosclerosis

Interventions

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.

Sponsors & Collaborators

  • Stryker Neurovascular

    lead INDUSTRY

Principal Investigators

  • Michael J Alexander, M.D. · Cedars-Sinai Medical Center

  • Wengui Yu, M.D. · University of California, Irvine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034058 on ClinicalTrials.gov