Actively Recruiting

Age: 18Years +
All Genders
NCT05823519

Neck Evolution With Ovation in Spain

Led by DGM Vascular · Updated on 2023-04-21

120

Participants Needed

9

Research Sites

239 weeks

Total Duration

On this page

Sponsors

D

DGM Vascular

Lead Sponsor

H

Hospital Universitario Central de Asturias

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Neck Evolution With Ovation in Spain

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female at least 18 years old.
  • Subject has signed informed consent for data release.
  • Subjects with de novo infrarenal AAA or aorto-iliac AAA eligible for endovascular repair with the Ovation Alto Endograft according to current instructions for use.
Not Eligible

You will not qualify if you...

  • Currently participating in another study where the primary endpoint has not been reached.
  • Currently participating in another study using the same devices or with the same primary endpoint.
  • Known allergy to any components of the device.
  • Pregnant (for females of childbearing potential).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, Spain, 07120

Actively Recruiting

2

Hospital Universitario De Girona Dr. Josep Trueta

Girona, Barcelona, Spain, 17007

Actively Recruiting

3

Hospital Universitario De Cruces

Barakaldo, Bizkaia, Spain, 48903

Actively Recruiting

4

Hospital Universitario De Burgos

Burgos, Castille and León, Spain, 09006

Actively Recruiting

5

Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain, 37007

Actively Recruiting

6

Hospital General Universitario De Toledo

Toledo, Castille-La Mancha, Spain, 45007

Actively Recruiting

7

Hospital Universitario De Cabueñes

Gijón, Principality of Asturias, Spain, 33394

Actively Recruiting

8

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain, 08025

Actively Recruiting

9

Hospital Universitario Germans Trias i Pujol

Barcelona, Spain, 08916

Actively Recruiting

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Research Team

M

Manuel Alonso Pérez, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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