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.
Conditions
- Aortic Aneurysm, Thoracic
- Penetrating Ulcer
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
- Allocation
- N/A
- 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. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Bolton Medical
Study Contact
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.