Neck Evolution With Ovation in Spain
DGM Vascular
120 participants
Jun 1, 2022
OBSERVATIONAL
Conditions
Summary
This is a multicenter, observational, prospective, single arm registry using Ovation Alto Endograft. A minimum of 50 up to a maximum of 120 subjects undergoing endovascular repair with Ovation Alto endograft will be enrolled and followed procedurally to discharge, at 1month, 6 months, 1 year and yearly afterward up to 3 years. This registry of Ovation Alto endograft will provide further assessment to confirm continuing safety and effectiveness of the graft and to confirm the stability of the neck diameter over time when treated with this device.
Eligibility
Inclusion Criteria3
- Male or female at least 18 years old.
- Subject has signed informed consent for data release.
- Subjects with de novo infrarenal AAA /aorto-iliac AAA and eligible for endovascular Abdominal Aortic Aneurysm Repair with the Ovation Alto Endograft according to current IFU.
Exclusion Criteria4
- Currently participating in another study where primary endpoint has not been reached yet.
- Currently participating in another study with the same devices and/or the same primary endpoint.
- Known allergy to any of the device components.
- Pregnant (females of childbearing potential only).
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Interventions
Implantation of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT05823519