NCT01092117

Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System

A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation™ Abdominal Stent Graft System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: TriVascular, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to determine whether the Ovation Abdominal Stent Graft System is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in those patients considered to be suitable candidates for open surgical repair.

Detailed description

This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when used in the treatment of patients with AAA (Treatment Group) as compared to a performance goal (Control Group). 150 study patients will be enrolled at up to 40 institutions. An additional 100 study patients will be enrolled in the continued access phase.

Conditions

• Aortic Aneurysm, Abdominal

Interventions

Type	Name	Description
DEVICE	Ovation™ Abdominal Stent Graft System	Implant of Ovation™ Abdominal Stent Graft System

Timeline

• Start date: 2010-04-29
• Primary completion: 2017-12-20
• Completion: 2017-12-20
• First posted: 2010-03-24
• Last updated: 2021-12-21
• Results posted: 2021-12-21

Locations

1 site across 1 country: United States