Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|