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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Thoracic Aortic Aneurysms, and Penetrating Atherosclerotic Ulcers

Intervention / Treatment
-----------------
* Device: Relay Thoracic Stent-Graft
* Procedure: Open Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Endovascular Treatment arm to be implanted with Relay device | Device: Relay Thoracic Stent-Graft<br>* implant<br>|
| Active Comparator: 2<br>Surgical Control, underwent open repair | Procedure: Open Repair<br>* Open surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects | 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. | 1 year | 
| Primary Safety Endpoint: Distribution of Major Adverse Events | 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 | 1 year |