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

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.

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Key information

Conditions

Thoracic Aortic Aneurysms Acute Aortic Syndrome Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Penetrating Atherosclerotic Ulcer Vascular Diseases and Penetrating Atherosclerotic Ulcers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Heart Hospital, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relay Thoracic Stent-Graft

Device

implant

Open Repair

Procedure

Open surgery

Primary outcomes

Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects

Time frame: 1 year

The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure.

The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.
Primary Safety Endpoint: Distribution of Major Adverse Events

Time frame: 1 year

The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure

Sponsors and collaborators

Lead sponsor

Bolton Medical

Industry

Registry information

Official study title

Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2017
First posted: Feb 16, 2007
Registry last updated: Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed