Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System

Status Completed

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

Clinical Trial Details

NCT number	NCT01092117
Study type	Interventional
Source	Endologix
Contact
Status	Completed
Phase	N/A
Start date	April 29, 2010
Completion date	December 20, 2017

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See also
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