RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
Purpose
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.
Condition
- Aortic Aneurysm, Thoracic
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RelayPro |
Endovascular treatment with the investigational device. |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- NCT ID
- NCT02818972
- Status
- Recruiting
- Sponsor
- Bolton Medical
Detailed 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.