Neck Evolution With Ovation in Spain

NCT05823519 | Recruiting DMC FDA Device

• 1 other identifier: NEOVAS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 9

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Alto Endograft; Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (5)

• Post-implant infrarenal aneurysm's neck grow evaluation

  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)

  30 days

• Post-implant infrarenal aneurysm's neck grow evaluation

  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)

  6 months

• Post-implant infrarenal aneurysm's neck grow evaluation

  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)

  1 year

• Post-implant infrarenal aneurysm's neck grow evaluation

  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)

  2 years

• Post-implant infrarenal aneurysm's neck grow evaluation

  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)

  3 years

Secondary Outcomes (5)

• Procedural technical success

  Immediately after the procedure

• Aneurysm evaluation

  3 years

• Related mortality

  3 years

• Secondary Evaluations

  3 years

• Polymer leak

  3 years

Study Arms (1)

SINGLE Arm

Observational, Multicenter, Prospective, single arm registry study with consecutive, eligible patient enrollment at each site. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 3 years (total follow-up commitment), with follow up including Computed tomography angiography (CTA) study and Case Report Form data at 1 month, 6 months, 1 years, 2 years and 3 years, closing at this time the study primary endpoint.

Device: Endologix Ovation Alto Endograft

Interventions

Endologix Ovation Alto Endograft DEVICE

Implantation of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms

SINGLE Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female at least 18 years old with aortic abdominal aneurysm with characteristics within the IFU of de device

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• DGM Vascular: lead
• Hospital Universitario Central de Asturias: collaborator

Study Sites (9)

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

RECRUITING

Hospital Universitario De Girona Dr. Josep Trueta

Girona, Barcelona, 17007, Spain

RECRUITING

Hospital Universitario De Cruces

Barakaldo, Bizkaia, 48903, Spain

RECRUITING

Hospital Universitario De Burgos

Burgos, Castille and León, 09006, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

RECRUITING

Hospital General Universitario De Toledo

Toledo, Castille-La Mancha, 45007, Spain

RECRUITING

Hospital Universitario De Cabueñes

Gijón, Principality of Asturias, 33394, Spain

RECRUITING

Hospital De La Santa Creu I Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Universitario Germans Trias i Pujol

Barcelona, 08916, Spain

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Manuel Alonso Pérez, MD

  Hospital Universitario Central de Asturias

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Alonso Pérez, MD

CONTACT

985 10 80 00; manuel.alonsop@sespa.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 21, 2023
• Study Start: June 1, 2022
• Primary Completion: January 1, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)