N/A
Completed N=75
Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
Aortic Aneurysm, Abdominal
Source: ClinicalTrials.gov NCT02949297 ↗
Enrolled (actual)
75
Serious AEs
14.7%
Results posted
Dec 2021
Primary outcomePrimary: Number of Subjects With Treatment Success — 58 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment Success |
58 | — |
| SECONDARY Event Rates for Endoleaks |
0; 1; 0; 34; 0; 0 | — |
| SECONDARY Number of Participants With Stent Graft Migration > 10mm |
0; 0 | — |
| SECONDARY Number of Participants With AAA Enlargement > 5mm |
0; 1 | — |
| SECONDARY Number of Participants With AAA Rupture |
0; 0 | — |
| SECONDARY Number of Participants With Conversion to Open Repair |
0; 1 | — |
| SECONDARY Number of Secondary Interventions |
0; 2 | — |
| SECONDARY Number of Participants With AAA-related Mortality |
0; 0 | — |
| SECONDARY Device-related Adverse Events (AEs) |
0; 1; 1; 0 | — |
| SECONDARY Major Adverse Events |
0; 3; 3; 0; 0; 1 | — |
| SECONDARY Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression) |
0; 0; 0 | — |
| SECONDARY Number of Participants With Stent Fracture |
0; 0; 0 | — |
| SECONDARY Adverse Events (Serious and Non-serious) |
0; 0; 0; 4; 13; 0 | — |
| SECONDARY Procedure-related Adverse Event |
2; 0; 3; 1; 0; 0 | — |
| SECONDARY Serious Adverse Event |
0; 2; 0; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria include:
- Patient has adequate iliac/femoral access compatible with the required delivery systems.
- Patient has non-aneurysmal proximal aortic neck.
- Patient has non-aneurysmal distal iliac landing zone.
Exclusion Criteria include:
- Patient has dissecting aneurysm.
- Patient has acutely ruptured aneurysm.
- Patient has need for emergent surgery.
Data sourced from ClinicalTrials.gov (NCT02949297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.