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Neck Evolution With Ovation in Spain
Sponsor: DGM Vascular
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2022-06-01
Completion Date
2027-01-01
Last Updated
2023-04-21
Healthy Volunteers
No
Conditions
Interventions
Endologix Ovation Alto Endograft
Implantation of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms
Locations (9)
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario De Girona Dr. Josep Trueta
Girona, Barcelona, Spain
Hospital Universitario De Cruces
Barakaldo, Bizkaia, Spain
Hospital Universitario De Burgos
Burgos, Castille and León, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital General Universitario De Toledo
Toledo, Castille-La Mancha, Spain
Hospital Universitario De Cabueñes
Gijón, Principality of Asturias, Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, Spain