NCT02009644

Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms

A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Bolton Medical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).

Detailed description

This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150 subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites. Upon completion of enrollment of150 subjects, an additional 50 subjects may be treated with the Treovance Stent-Graft at the 30 investigative sites participating in the trial. These additional subjects will follow the same study schedule, and data from these patients may be used to supplement the pivotal trial data. There will be no prospective control group. Subjects diagnosed with infrarenal abdominal aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months post-implantation. In addition, annual follow-up visits out to 5 years will be conducted. Subjects with fracture(s) confirmed by the Core Lab within the first 5 years will be followed for an additional 5 years, for a total of 10 years post-implantation. The primary goal of this study is to gather safety and effectiveness data on the Treovance device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II requirements. The data from this study will be submitted to the FDA and used to support approval in the U.S. There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in subjects with infrarenal aortic aneurysms: * Primary Efficacy will be evaluated by successful aneurysm treatment 12 months post-implant * Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days Secondary objectives involve assessment of major device-related events and major morbidity.

Conditions

• Abdominal Aortic Aneurysm (AAA)

Interventions

Type	Name	Description
DEVICE	Subjects who receive the Treovance stent-graft	Eligible subjects will be implanted with the Treovance Stent-Graft

Timeline

• Start date: 2013-11-23
• Primary completion: 2017-03-20
• Completion: 2026-06-01
• First posted: 2013-12-12
• Last updated: 2026-01-28

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated device study