Technical Evaluation and Results of the Use of TREO® Modular Aortic Endografts for the Treatment of Abdominal Aortic Aneurysms
NCT06893952 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 209
Last updated 2025-03-25
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
- DEVICE
-
TREO Endograft
Post Market collection data in use of TREO modular endografts
Sponsors & Collaborators
-
Vascutek Ltd.
lead INDUSTRY
Eligibility
- Min Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-30
- Primary Completion
- 2025-04-30
- Completion
- 2031-12-31
- FDA Device
- Yes
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