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.
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
Enrollment
320
Single occurence permanent implant of AAA device.
Christie Clinical Vein and Vascular Center
Champaign, Illinois, United States
Freedom From Aneurysm-Related Mortality at 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.
Time frame: 5 Years
Composite Safety and Performance Endpoints
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 * Endoleak * AAA enlargement * Stent Graft Migration * Device integrity * Secondary endovascular procedures * Aneurysm rupture
Time frame: 1 Month & Annually 1 to 5 Years
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