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NCT07026877 · ClinicalTrials.gov registry record · NA
Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA
A NA study of Abdominal Aortic Aneurysms (AAA), sponsored by Bolton Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 7
- Study locations
NCT07026877: Recruiting NA study of Abdominal Aortic Aneurysms (AAA), sponsored by Bolton Medical.
NCT07026877 is a NA study of Abdominal Aortic Aneurysms (AAA) that is actively recruiting participants, run by Bolton Medical. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07026877, a NA study of Abdominal Aortic Aneurysms (AAA), is actively recruiting participants, sponsored by Bolton Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 7
- Study locations
Study Summary
The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. It will also learn about the safety of Fenestrated TREO Stent-Graft System. The main question it aims to answer is: Can the the Fenestrated TREO Stent-Graft System be used to treat participants with a specific type of abdominal aneurysm called a juxtarenal abdominal aortic aneurysm? Participants will: Have the the Fenestrated TREO Stent-Graft System implanted via an endovascular surgical procedure and visit the hospital for a follow up period of 5 years, for checkups, tests and imaging scans.
Primary Outcome
The primary safety endpoint is the absence of a major adverse event (MAE) at 30-day post procedure. MAEs are defined as follows: * All-cause mortality, defined as death due to any cause * Myocardial infarction (new onset) based on the Society for Cardiovascular Angiography \& Interventions (SCAI) definition * Respiratory failure requiring prolonged (\>24 hours from anticipated) mechanical ventilation or reintubation * Renal function decline resulting in \>50% reduction from baseline estimated
Conditions Studied
Interventions
- DEVICE Fenestrated TREO Stent Graft System
Study Locations (7)
Colorado
- UC Health Memorial - Colorado Springs
Florida
- Tampa General Hospital - Tampa
Massachusetts
- Brigham and Women's Hospital - Boston
Missouri
- Washington University School of Medicine - St Louis
New York
- Mt. Sinai - New York
Texas
- Baylor Scott and White Research Institute - Plano
Washington
- University of Washington Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-11-18 |
| Est. Completion | 2030-05-29 |
| Phase | NA |
What NCT07026877 shows while recruiting
NCT07026877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Abdominal Aortic Aneurysms (AAA) appearing as the primary indexed condition, and to 1 intervention - of which Fenestrated TREO Stent Graft System is the first listed.
NCT07026877 lists 7 locations in 7 states (Colorado, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT07026877 about?
NCT07026877 is a clinical study titled "Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA". The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. It will also learn about the s...
What is the current status of trial NCT07026877?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-11-18. Estimated completion is 2030-05-29.
What conditions does trial NCT07026877 study?
This clinical trial studies the following conditions: Abdominal Aortic Aneurysms (AAA).
What interventions are being tested in trial NCT07026877?
The interventions under investigation include: Fenestrated TREO Stent Graft System (DEVICE).
Who is sponsoring clinical trial NCT07026877?
This trial is sponsored by Bolton Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07026877 being conducted?
This trial has 7 study locations across Colorado, Florida, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07026877's enrollment target sits among peer trials
20 1769th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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