A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

May 10, 2017
BH16-204
Heart, Surgery
Neal Hadro, MD
Baystate Medical Center, 759 Chestnut St, Springfield, MA
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.

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.
Interventional (Clinical Trial)
Natalie Gendron