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

NCT01327742 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2012-11-19

No results posted yet for this study

Summary

This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.

Conditions

  • Thoracic Aortic Aneurysm
  • Penetrating Ulcers

Interventions

DEVICE

Relay Thoracic Stent-Graft

Device implant

Sponsors & Collaborators

  • Bolton Medical

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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 NCT01327742 on ClinicalTrials.gov