NCT06893952

Technical Evaluation and Results of the Use of TREO® Modular Aortic Endografts for the Treatment of Abdominal Aortic Aneurysms

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 209 (estimated)
• Sponsor: Vascutek Ltd. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This study is a clinical investigation as part of the post-market clinical follow-up of the TREO® abdominal aortic graft in its initial use, French, observational, multicenter, non-randomized, single-arm. Information on patient's health and the implanted device will be collected over a period of 5 consecutive years. The data collected will be analyzed on the technical success and the absence of major events (death, stroke, myocardial infarction, visceral ischemia, paraplegia, respiratory failure, renal failure, intraoperative blood loss, thromboembolic event) and possible reinterventions related to the patient's operation.

Conditions

• Aortic Aneurysm Abdominal

Interventions

Type	Name	Description
DEVICE	TREO Endograft	Post Market collection data in use of TREO modular endografts

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-04-01
• Completion: 2031-12-01
• First posted: 2025-03-25
• Last updated: 2025-03-25

Regulatory

• FDA-regulated device study