Endologix Ovation Alto Endograft: Implantation of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Post-implant infrarenal aneurysm's neck grow evaluation — 30 days The neck diameter will be measured on Computed Tomography Angiography (CTA) at 0mm (lowest renal artery), 5mm, 10mm, 15mm and 20mm. No type I or III endoleak. No clinically significant migration (\>5mm). No Aneurysm enlargement (\>5mm)
Post-implant infrarenal aneurysm's neck grow evaluation — 6 months The neck diameter will be measured on Computed Tomography Angiography (CTA) at 0mm (lowest renal artery), 5mm, 10mm, 15mm and 20mm. No type I or III endoleak. No clinically significant migration (\>5mm). No Aneurysm enlargement (\>5mm)
Post-implant infrarenal aneurysm's neck grow evaluation — 1 year The neck diameter will be measured on Computed Tomography Angiography (CTA) at 0mm (lowest renal artery), 5mm, 10mm, 15mm and 20mm. No type I or III endoleak. No clinically significant migration (\>5mm). No Aneurysm enlargement (\>5mm)
Post-implant infrarenal aneurysm's neck grow evaluation — 2 years The neck diameter will be measured on Computed Tomography Angiography (CTA) at 0mm (lowest renal artery), 5mm, 10mm, 15mm and 20mm. No type I or III endoleak. No clinically significant migration (\>5mm). No Aneurysm enlargement (\>5mm)
Post-implant infrarenal aneurysm's neck grow evaluation — 3 years The neck diameter will be measured on Computed Tomography Angiography (CTA) at 0mm (lowest renal artery), 5mm, 10mm, 15mm and 20mm. No type I or III endoleak. No clinically significant migration (\>5mm). No Aneurysm enlargement (\>5mm)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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