Overview

This trial is active, not recruiting.

Conditions thoracic aortic aneurysms, and penetrating atherosclerotic ulcers
Treatment relay thoracic stent-graft
Phase phase 2
Sponsor Bolton Medical
Start date January 2007
End date April 2011
Trial size 120 participants
Trial identifier NCT00435942, IP-0004-06, NCT00998491

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Endovascular Treatment arm
relay thoracic stent-graft
implant
(Active Comparator)
Surgical Control
relay thoracic stent-graft
implant

Primary Outcomes

Measure
Major device-related adverse events and major morbidity & mortality
time frame: 1 year

Secondary Outcomes

Measure
clinical utility, lesion size increases, vascular complications
time frame: 1, 6, 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers - Subjects who are at least 18 years of age - Subjects whose anatomy can accommodate the Relay device - Subjects who consent to participate - Subjects who agree to comply with follow-up schedule Exclusion Criteria: - Subjects with non-aneurysm lesions - Subjects with less than 1 year life expectancy - Subjects who are pregnant - Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.) - Subjects participating in another investigational study

Additional Information

Official title Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
Principal investigator Mark Farber, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Bolton Medical.