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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01092117
Study type Interventional
Source TriVascular, Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 2010
Completion date December 2017

See also
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