Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
|ClinicalTrials.gov Identifier: NCT01980901|
Recruitment Status : Active, not recruiting
First Posted : November 11, 2013
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment|
|Aortic Aneurysm, Abdominal||Device: Ovation™/Ovation Prime™ Abdominal Stent Graft System|
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 Type :||Observational|
|Estimated Enrollment :||320 participants|
|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|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||October 2020|
Ovation™/Ovation Prime™ Abdominal Stent Graft System
Adult male and female patients.
Device: Ovation™/Ovation Prime™ Abdominal Stent Graft System
Single occurence permanent implant of AAA device.
- Freedom From Aneurysm-Related Mortality at 5 Years [ Time Frame: 5 Years ]The primary endpoint of the Ovation™/Ovation Prime™ Abdominal Stent Graft System study will be determined by evaluating freedom from aneurysm-related mortality at five (5) years. This will be compared to a target performance goal.
- Composite Safety and Performance Endpoints [ Time Frame: 1 Month & Annually 1 to 5 Years ]
Serious Adverse Events (SAEs) within 30 days of the initial procedure and through 12 months and annually thereafter to 5 years
At 30 days and 12 months and annually thereafter to 5 years, the following rates will be reported:
- Mortality (AAA-related and all-cause)
- Device patency
- Conversion to open surgical repair
- AAA enlargement
- Stent Graft Migration
- Device integrity
- Secondary endovascular procedures
- Aneurysm rupture
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980901
|United States, Illinois|
|Christie Clinical Vein and Vascular Center|
|Champaign, Illinois, United States, 61820|
|Principal Investigator:||Syed Hussain, MD||Christie Clinical Vein and Vascular Center|