N/A
N=75
Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
Aortic Aneurysm, Abdominal
Bottom Line
View on ClinicalTrials.gov: NCT02949297 ↗Enrolled (actual)
75
Serious AEs
14.7%
Results posted
Dec 2021
Primary outcome: Primary: Number of Subjects With Treatment Success — 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ovation Alto Abdominal Stent Graft System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endologix
- Primary completion
- Mar 2019
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 | — |
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).
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.