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Post-Approval Study of the TREO Abdominal Stent-Graft System
NCT04697784 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04697784
The ClinicalTrials.gov registry entry for NCT04697784 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 338 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bolton Medical, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04697784 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04697784?
The interventions under investigation include: TREO Abdominal Stent-Graft System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04697784?
This trial is sponsored by Bolton Medical, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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