Actively Recruiting
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
Eligibility Criteria
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.
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
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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
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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