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

Bolton Medical180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

Interventions

Relay Thoracic Stent-GraftDEVICE

implant

Open RepairPROCEDURE

Open surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.