Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Aneurysm, Abdominal
- Sponsor
- Endologix
- Enrollment
- 75
- Locations
- 13
- Primary Endpoint
- Number of Subjects With Treatment Success
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).
Detailed Description
A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA). The primary objective is to evaluate treatment success at 12 months with the Ovation Alto Abdominal Stent Graft system. The study will have up to 16 sites, and up to 75 patients based on attrition rates. The follow-up intervals will be at 1, 6, and 12 months following initial implant procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Subjects With Treatment Success
Time Frame: 12 months
Treatment success is defined as technical success, freedom from type I and III endoleaks at 12 months, freedom from stent graft migration \> 10m at 12 months compared to 1 month baseline, freedom from AAA enlargement \>5mm at 12 months (compared to 1-month baseline, freedom from AAA rupture through 12 months, freedom from conversion to open repair through 12 months, stent graft stenosis, occlusion or kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months.
Secondary Outcomes
- Number of Participants With AAA Enlargement > 5mm(6 months, 12 months)
- Number of Participants With Conversion to Open Repair(30 day, Day 31-365)
- Number of Participants With AAA-related Mortality(1 month, Day 31-365)
- Major Adverse Events(1 year)
- Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)(1 month, 6 months, 12 months)
- Number of Participants With Stent Fracture(1 month, 6 months, 12 months)
- Adverse Events (Serious and Non-serious)(30 days, Day 31-365)
- Event Rates for Endoleaks(1 month, 6 months, 12 months)
- Number of Participants With Stent Graft Migration > 10mm(6 months, 12 months)
- Number of Participants With AAA Rupture(30 day, Day 31-365)
- Number of Secondary Interventions(30 days, Day 31-365)
- Device-related Adverse Events (AEs)(30 days, Day 31-365)
- Procedure-related Adverse Event(30 days, Day 31-365)
- Serious Adverse Event(30 Days, Day31-365))