Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA

Conditions

• Abdominal Aortic Aneurysms (AAA)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fenestrated TREO Stent Graft System — DEVICE
  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).

Study Details

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.

Key Dates

Start date

Nov 18, 2025

Status verified

May 2025

Primary completion

May 29, 2027

Completion

May 29, 2030

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Stage 1 - Roll-in Arm
  Minimum of 20 subjects (up to 30) with juxtarenal Abdominal Aortic Aneurysm (AAA), being treated with the Fenestrated TREO Stent-Graft System

Primary Outcome Measure

Proportion of patients with absence of a major adverse event (Primary Safety Endpoint) [ Time Frame: 30-day post-procedure ]

Central Contacts

• Lauren Rider
  19545470374
  [email protected]
• Valerie Merkle
  +1 954 838 9699
  [email protected]

Locations (7)

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