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

Description

The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Relay Thoracic Stent-Graft in subjects with TAA compared to surgical repair subjects. This is a phase II multi-center, non-blinded, non-randomized study of treatment of the Relay Thoracic Stent-Graft in subjects with thoracic aortic aneurysms. The study will include 120 subjects treated with the Relay Thoracic Stent-Graft and 60 surgical controls enrolled at a maximum of 30 investigational sites. Pre-procedure baseline data will be gathered along with post-procedure assessments prior to hospital discharge and 1, 6, and 1-year post-implantation follow-ups in addition to an annual visit out to 5 years. Study Objectives There are two primary objectives: efficacy and safety. - Primary Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1- year. - Primary 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 open surgical repair. Secondary objectives include evaluation of the primary outcomes including endoleak (Type I, III and IV only), stent migration, lumen occlusion, deployment failure/conversion to surgery, and aneurysm rupture at time points other than 1-year; evaluation of individual outcomes of the composite safety endpoints (e.g., stroke, paraplegia, myocardial infarction, respiratory failure, renal failure, and aneurysm-related mortality) at time points other than 1-year; comparison of the clinical utilities (duration of procedure, procedural blood loss, length of ICU and hospital stay, time in ICU) of the endovascular and surgical repair groups; device integrity failures, vascular access difficulties and analysis of the change in lesion size at 6-months, 1 year, and 2 -5 years post-procedure as compared to 1-month. It is planned to enroll 120 subjects with diagnosed TAA into the endovascular cohort. Sixty (60) surgical controls will also be included. For purposes of this study protocol, surgical controls, or surgical subjects, are those treated by open surgical repair. The study will be conducted at a maximum of 30 investigational sites in order to enroll the patient population needed for analysis. Subjects will be enrolled on a first come / first serve basis; however, a single investigational site may not enroll more than 30% of the enrollment total.

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