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.
Patient who has confirmed his/her non-opposition to the use of his/her data in the study.
Patient aged 45 years or older.
Maximum diameter ≥50 mm for women and ≥55 mm for men
Rapid growth (≥5 mm in 6 months or ≥10 mm in 12 months)
Patients refusing treatment and follow-up as part of the study
Infected or ruptured aneurysm
Associated aortic lesion (thoracic or thoracoabdominal aneurysm) requiring management
Renal failure defined by creatinine > 2.5 mg/dL or patient in pre-dialysis status and impossibility of intervention with use of CO2 injection
Patients with: * an asymptomatic infrarenal abdominal aortic aneurysm with a largest diameter greater than 5.5 cm in men and 5 cm in women or if the diameter increases by 1 cm in 1 year (for an aneurysm with a diameter greater than 4 cm). * a symptomatic infrarenal abdominal aortic aneurysm, regardless of the size.
Cohort
Prospective
TREO Endograft
DevicePost Market collection data in use of TREO modular endografts
The primary outcomes of this study are the rate of a composite measure of technical and clinical success at 1 and 12 months to assess efficacy, and the rate of a composite measure of free from major adverse events at 1 month to assess safety.
Definition of the composite of technical success: * Successful access to the arterial system using remote arterial exposure, percutaneous technique, surgical access, or open surgical conduits. * Successful delivery and deployment of all components of the modular stent graft. * Absence of type I or type III endoleaks at the end of angiography that extend beyond 30 days confirmed by imaging\*. * Patency of all components of the modular stent graft. Definition of the composite of clinical success : * Technical success * No death during the initial procedure, related to the procedure or from aortic-related causes during the initial hospitalization * No type I and III endoleaks, at 1 and 12 months * No early migration (\> 10 mm), at 1 and 12 months * No increase in maximum sac diameter of more than 5 mm between 1 and 12 months * No aneurysm rupture, at 1 and 12 months * No surgical conversion related to aneurysm treatment, at 1 and 12 months
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
