NCT01980901

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 320 (actual)
• Sponsor: TriVascular, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aortic Aneurysm, Abdominal

Interventions

Type	Name	Description
DEVICE	Ovation™/Ovation Prime™ Abdominal Stent Graft System	Single occurence permanent implant of AAA device.

Timeline

• Start date: 2013-10-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2013-11-11
• Last updated: 2021-06-04

Locations

1 site across 1 country: United States