Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bolton Medical
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
