Status:
ACTIVE_NOT_RECRUITING
Post-Approval Study of the TREO Abdominal Stent-Graft System
Lead Sponsor:
Bolton Medical
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
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 Ane...
Eligibility Criteria
Inclusion
- 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
- • Medical, social or psychological problems that, in the opinion of the investigator, preclude patient from receiving treatment with the TREO Abdominal Stent-Graft System.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2027
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT04697784
Start Date
January 20 2021
End Date
July 31 2027
Last Update
June 26 2025
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
Vascular Surgery Specialists
Phoenix, Arizona, United States, 85006
2
Pima Heart and Vascular
Tucson, Arizona, United States, 85718
3
University of California, San Francisco-Fresno
Fresno, California, United States, 93701
4
University of California, San Diego
La Jolla, California, United States, 92037