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Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System

Aortic Aneurysm, Abdominal Clinical Trial

Official title:
A Post-Market Approved (PMA) Post-Approval Study to Evaluate the Long-Term Safety and Effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System

Clinical Trial Summary

The Post-Approval Study (PAS) will evaluate the "real world" data on the Ovation™/Ovation Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE cohort to monitor the long-term safety and effectiveness of the device.

Clinical Trial Description

The purpose of the study is to demonstrate the long term safety and effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment. The clinical objective of the study is to evaluate the long term safety and effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality. Additionally, this study will evaluate the physician training program for modifications based on IDE and post-approval experience. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01980901
Study type Observational
Source Endologix
Contact
Status Completed
Phase
Start date October 2013
Completion date September 1, 2020
View Details
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