Summary

Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.

Age: 18 Years and older

Gender: All

Start Date: 05/10/2017

Primary Completion Date (Estimated): 06/24/2022

Study Completion Date (Estimated): 12/01/2025

Accepts Healthy Volunteers: No

Trial Purpose and Description

The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

Inclusion criteria:

* Subject must be ≥ 18 years of age

* Subject has specified disease in his/her descending thoracic aorta.

* Subject have anatomical compliance for the device specified for both access vessels and treatment area.

* Subject must be willing to comply with the follow-up evaluation schedule.

* Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.

Exclusion criteria:

* Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm.

* Subject anatomy with significant stenosis, calcification, thrombus or tortuosity.

* Subjects with specified compromised circulation.

* Subjects with specified prior procedures.

* Subjects with allergy to contrast media or device components.

* Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure.

* Subjects that are pregnant or planning to become pregnant during the course of the study.