Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR) with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years; infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or thrombus formation; infrarenal or distal iliac landing neck size requirements specified in the instructions for use. Main exclusion criteria: dissection/ruptured aneurysm or prior AAA endovascular or surgical repair. The primary endpoints were standard EVAR criteria.
The goal of the registry was to collect clinical data of TREOVANCE® device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology is treated with an acceptable technical success rate, an acceptable complication rate and that the device performs as expected. The following endovascular measures/parameters were assessed for preliminary performance at the follow-up intervals: delivery/deployment, stent-graft migration, stent-graft patency, stent-graft integrity, endoleak, aneurysm sac size changes, limb ischemia, and vascular access complications. This registry was a prospective, multi-center, post-market non-randomized study. The goal was to gather safety and performance data on the device. Subjects diagnosed with infrarenal aortic aneurysms enrolled into the registry were treated with the TREOVANCE® Stent-Graft with Navitel® Delivery System. Pre-procedure baseline data was gathered as well as post-procedure assessments prior to hospital discharge and 1, 6, and 12 months post-implantation.
Study Type
OBSERVATIONAL
Enrollment
202
Endovascular repair of abdominal aortic aneurysms.
Number of subjects reporting Major Adverse Events
Primary safety outcome will be assessed by measurement of mortality and major morbidity rates through reporting of the following events: * Death * Stroke * Myocardial Infarction * Renal Failure requiring renal replacement therapy * Respiratory Failure, defined as ventilator-dependent * Paraparesis / Paraplegia (excludes paraparesis) * Bowel ischemia * Treated aneurysm rupture
Time frame: Through 12 months
Rate of Device Delivery/Deployment Success
Device effectiveness will be measured through the rate of successful delivery and deployment during the index procedure
Time frame: Procedure / Study Day 0
Rate of Stent-Graft Migration greater than 10mm
Device effectiveness will be measured by the rate of Stent-Graft Migration greater than 10mm as compared to the first post procedure imaging
Time frame: 6 months and 12 months
Rate of Stent-Graft Patency
Device effectiveness will be measured by the rate of Stent-Graft Patency observed
Time frame: 1 month, 6 months and 12 months
Rate of Stent-Graft Integrity
Device effectiveness will be measured by the rate of Stent-Graft Integrity observed
Time frame: 1 month, 6 months and 12 months
Rate of Endoleaks
Device effectiveness will be measured by the rate of Endoleaks reported
Time frame: 1 month, 6 months and 12 months
Rate of Aneurysm Sac Size Changes
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Hospital Barros Luco Trudeau
Santiago, Chile
Hospital de la Dirección de Previsión de Carabineros de Chile
Santiago, Chile
Rigshospitalet, National Hospital and University of Copenhagen
Copenhagen, Denmark
Deutsches Herzzentrum Berlin
Berlin, Germany
Bonifatius Hospital
Lingen, Germany
Theresienkrankenhaus und St. Hedwig-Klinik
Mannheim, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Evaggelismos General Hospital
Athens, Greece
Georgios Gennimatas Thessaloniki General Hospital
Thessaloniki, Greece
Queen Mary Hospital, University of Hong Kong
Hong Kong, Hong Kong
...and 22 more locations
Device effectiveness will be measured by the rate of Aneurysm Sac Size Changes at 6 months and 12 months as compared to the first post-procedure imaging
Time frame: 6 months and 12 months
Rate of Limb Ischemia
Device effectiveness will be measured by the rate of Limb Ischemia resulting in limb loss
Time frame: 1 month, 6 months and 12 months
Rate of Vascular Access Complications
Device effectiveness will be measured by the rate of Vascular Access Complications
Time frame: 1 month, 6 months and 12 months
Rate of unintentional covering of renal arteries and / or hypogastric arteries
Device effectiveness will be measured by the rate of unintentional covering of renal arteries and / or hypogastric arteries during the index procedure
Time frame: Procedure / Study Day 0