Neck Evolution With Ovation in Spain

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitario De Cruces
RECRUITING
Barakaldo
Hospital De La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Universitario Germans Trias i Pujol
RECRUITING
Barcelona
Hospital Universitario De Burgos
RECRUITING
Burgos
Hospital Universitario De Cabueñes
RECRUITING
Gijón
Hospital Universitario De Girona Dr. Josep Trueta
RECRUITING
Girona
Hospital Universitari Son Espases
RECRUITING
Palma De Mallorca
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital General Universitario De Toledo
RECRUITING
Toledo
Contact Information
Primary
Manuel Alonso Pérez, MD
manuel.alonsop@sespa.es
985 10 80 00
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 120
Treatments
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.
Sponsors
Leads: DGM Vascular
Collaborators: Hospital Universitario Central de Asturias

This content was sourced from clinicaltrials.gov