About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- TREO Endograft