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NCT04697784 · ClinicalTrials.gov registry record · NA
Post-Approval Study of the TREO Abdominal Stent-Graft System
A NA study of Abdominal Aortic Aneurysm, sponsored by Bolton Medical.
- Active
- Registry status
- NA
- Development phase
- 338
- Enrollment target
- 20
- Study locations
NCT04697784: Active NA study of Abdominal Aortic Aneurysm, sponsored by Bolton Medical.
NCT04697784 is a NA study of Abdominal Aortic Aneurysm that is active but no longer recruiting, run by Bolton Medical. The registered enrollment target is 338 participants, below the 433-participant average among 16 other Abdominal Aortic Aneurysm trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04697784, a NA study of Abdominal Aortic Aneurysm, is active but no longer recruiting, sponsored by Bolton Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 338 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Incidence of fracture in a stent-strut or separation of one or more proximal fixation barbs as confirmed by the Imaging Core Laboratory upon review of post-implant imaging studies.
Conditions Studied
Interventions
- DEVICE TREO Abdominal Stent-Graft System
Study Locations (20)
Florida
- Malcom Randall VA Medical Center - Gainesville
- University of Florida - Gainesville
- Coastal Vascular and Interventional - Pensacola
- University of South Florida / Tampa General Hospital - Tampa
California
- University of California, San Francisco-Fresno - Fresno
- University of California, San Diego - La Jolla
- VA San Diego - San Diego
Arizona
- Vascular Surgery Specialists - Phoenix
- Pima Heart and Vascular - Tucson
Georgia
- Piedmont Heart Institute - Atlanta
- Northside Hospital - Atlanta
Massachusetts
- Tufts Medical Center - Boston
- Massachusetts General Hospital - Boston
Michigan
- McLaren Bay Region - Bay City
- Henry Ford Hospital - Detroit
Colorado
- University of Colorado Anschutz - Aurora
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2021-01-20 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
What the registry record for NCT04697784 still lists
NCT04697784 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 433-participant average among 16 other Abdominal Aortic Aneurysm trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Abdominal Aortic Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which TREO Abdominal Stent-Graft System is the first listed.
NCT04697784 names 20 study sites across 11 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04697784 about?
NCT04697784 is a clinical study titled "Post-Approval Study of the TREO Abdominal Stent-Graft System". 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.
What is the current status of trial NCT04697784?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 338 participants. The study started on 2021-01-20. Estimated completion is 2027-07-31.
What conditions does trial NCT04697784 study?
This clinical trial studies the following conditions: Abdominal Aortic Aneurysm.
What interventions are being tested in trial NCT04697784?
The interventions under investigation include: TREO Abdominal Stent-Graft System (DEVICE).
Who is sponsoring clinical trial NCT04697784?
This trial is sponsored by Bolton Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04697784 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04697784's enrollment target sits among peer trials
338 7th of 16 higher than 10 of 16 other Abdominal Aortic Aneurysm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Abdominal Aortic Aneurysm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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