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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorVascutek Ltd.

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

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators