Post-Approval Study of the TREO Abdominal Stent-Graft System
Purpose
The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms.
Condition
- Abdominal Aortic Aneurysm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Willing and able to comply with all study procedures and visits. - Written informed consent to participate in the study. - Patient's aneurysm can be treated with the TREO Abdominal Stent-Graft System. - Adequate data (medical records/imaging studies) available to analyze the primary endpoints for patients enrolled retrospectively.
Exclusion Criteria
• Medical, social or psychological problems that, in the opinion of the investigator, preclude patient from receiving treatment with the TREO Abdominal Stent-Graft System.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Abdominal Aortic Aneurysm Stent-Graft
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Subjects who receive the TREO Abdominal Stent-Graft System |
Eligible subjects will be implanted with the TREO Abdominal Stent-Graft System. |
|
Recruiting Locations
Pensacola, Florida 32504
Bay City, Michigan 48708
Austin, Texas 78756
More Details
- NCT ID
- NCT04697784
- Status
- Recruiting
- Sponsor
- Bolton Medical
Detailed Description
This is a prospective, multi-center, non-randomized, single-arm, post-market, non-interventional study of treatment with the TREO Abdominal Stent-Graft in subjects with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms. The study will include a minimum of 300 subjects treated with the TREO Abdominal Stent-Graft at up to 55 investigational sites in the US. The primary objective is the collection of real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of AAA in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.