NCT00646048

A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	TriVascular Stent-Graft System	TriVascular Stent-Graft System

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-11-01
• Completion: 2010-03-01
• First posted: 2008-03-28
• Last updated: 2011-01-28
• Results posted: 2011-01-19

Locations

7 sites across 1 country: United States