An observational study in Abdominal Aortic Aneurysm, sponsored by Bolton Medical. Completed at 32 sites in 17 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-06-26.
Sponsored by Bolton Medical · Observational
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.
Subjects diagnosed with infrarenal aortic aneurysms requiring endovascular repair.
Exclusion Criteria:
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
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
Summary results of procedural data and outcomes
Procedural data and outcomes will be summarized descriptively, including: * Type of anesthesia * Duration of procedure time (first cut to last stitch) * Time in ICU * Duration of hospitalization * Volume of blood loss * Volume of blood replaced * Subjects requiring blood transfusion * Type of arterial access (percutaneous, cut down) * Reinterventions
Time frame: 1 month, 6 months and 12 months
Plan to share: Undecided
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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