NCT01328197

Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bolton Medical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.

Conditions

• Abdominal Aortic Aneurysms

Interventions

Type	Name	Description
DEVICE	Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System	Stent-graft implant

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-04-01
• Completion: 2017-06-01
• First posted: 2011-04-04
• Last updated: 2017-12-20

Locations

6 sites across 1 country: United States