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Recruiting NCT05823519

Neck Evolution With Ovation in Spain

Trial Parameters

Condition Abdominal Aortic Aneurysm
Sponsor DGM Vascular
Study Type OBSERVATIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-06-01
Completion 2024-01-01
Interventions
Endologix Ovation Alto Endograft

Brief 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 Criteria

Inclusion Criteria: 1. Male or female at least 18 years old. 2. Subject has signed informed consent for data release. 3. 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 Criteria: 1. Currently participating in another study where primary endpoint has not been reached yet. 2. Currently participating in another study with the same devices and/or the same primary endpoint. 3. Known allergy to any of the device components. 4. Pregnant (females of childbearing potential only).

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