NCT03449875

Global Post-market Registry for the Treovance Stent-graft.

A Post-Market Surveillance Clinical Registry of the TREOVANCE® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 202 (actual)
• Sponsor: Bolton Medical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	TREOVANCE® Stent-Graft with Navitel® Delivery System	Endovascular repair of abdominal aortic aneurysms.

Timeline

• Start date: 2014-02-05
• Primary completion: 2017-04-11
• Completion: 2017-04-11
• First posted: 2018-02-28
• Last updated: 2020-06-26

Locations

32 sites across 17 countries: Chile, Denmark, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden, Thailand, United Kingdom, Venezuela, Vietnam