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Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

NCT00435942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-01-16

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.

Conditions

  • Thoracic Aortic Aneurysms
  • and Penetrating Atherosclerotic Ulcers

Interventions

DEVICE

Relay Thoracic Stent-Graft

implant

PROCEDURE

Open Repair

Open surgery

Sponsors & Collaborators

  • Bolton Medical

    lead INDUSTRY

Principal Investigators

  • Mark Farber, MD · University of North Carolina

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-04-30
Completion
2017-05-15

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 NCT00435942 on ClinicalTrials.gov