Observational registry for the Ovation Alto Endograft in treating abdominal aortic aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, observational registry aims to assess the safety and effectiveness of the Ovation Alto Endograft in patients undergoing endovascular repair for abdominal aortic aneurysms (AAA). A total of 50 to 120 subjects will be enrolled and followed from the procedure to discharge, and then at 1 month, 6 months, 1 year, and annually for up to 3 years. The study will focus on confirming the stability of the neck diameter over time and monitoring any complications associated with the graft. This approach will provide valuable data on the long-term outcomes of this treatment method.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female at least 18 years old.
2. Subject has signed informed consent for data release.
3. 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.

Exclusion Criteria:

1. Currently participating in another study where primary endpoint has not been reached yet.
2. Currently participating in another study with the same devices and/or the same primary endpoint.
3. Known allergy to any of the device components.
4. Pregnant (females of childbearing potential only).

Where it's running

• Hospital Universitari Son Espases
  Palma de Mallorca, Balearic Islands, Spain Recruiting
• Hospital Universitario De Girona Dr. Josep Trueta
  Girona, Barcelona, Spain Recruiting
• Hospital Universitario De Cruces
  Barakaldo, Bizkaia, Spain Recruiting
• Hospital Universitario De Burgos
  Burgos, Castille and León, Spain Recruiting
• Hospital Universitario de Salamanca
  Salamanca, Castille and León, Spain Recruiting
• Hospital General Universitario De Toledo
  Toledo, Castille-La Mancha, Spain Recruiting

Study contacts

• Principal investigator: Manuel Alonso Pérez, MD — Hospital Universitario Central de Asturias
• Study coordinator: Manuel Alonso Pérez, MD
• Email: manuel.alonsop@sespa.es
• Phone: 985 10 80 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.