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Neck Evolution With Ovation in Spain

NCT05823519 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-04-21

No results posted yet for this 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.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

Endologix Ovation Alto Endograft

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

Sponsors & Collaborators

  • Hospital Universitario Central de Asturias

    collaborator OTHER

  • DGM Vascular

    lead NETWORK

Principal Investigators

  • Manuel Alonso Pérez, MD · Hospital Universitario Central de Asturias

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-01-01
Completion
2027-01-01
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05823519 on ClinicalTrials.gov