NCT07026877

Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA

A Prospective, Multicenter, Non-Blinded, Non-Randomized Pivotal Study of the Fenestrated TREO Stent-Graft System in Subjects With Abdominal Aortic Aneurysms Requiring a Fenestrated Graft and Suitable for Endovascular Repair

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Bolton Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysms (AAA)

Interventions

Type	Name	Description
DEVICE	Fenestrated TREO Stent Graft System	The Fenestrated TREO Stent-Graft System is a modular, endoluminal, over-the-wire system intended for the endovascular treatment of juxtarenal and pararenal to paravisceral aneurysms requiring a fenestrated stent-graft and having suitable morphology. The system is composed of the following components: Fenestrated TREO Bifurcate Stent-Graft - The main body fenestrated bifurcate provides the following; proximal seal, fenestrations and gates for connection to the leg extensions. Bridging Stents - The bridging stent connects the main body bifurcated device to the target visceral artery allowing the target anatomy to maintain perfusion while keeping the pathology sealed TREO Leg and Straight Extension Stent-Grafts: The Leg Extension and Straight Extension stent-grafts are used to complete coverage of the pathology from the main body bifurcated device to the distal landing zones (usually the common iliac artery just proximal to the iliac bifurcation).

Timeline

• Start date: 2025-11-18
• Primary completion: 2027-05-29
• Completion: 2030-05-29
• First posted: 2025-06-18
• Last updated: 2026-02-18

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study