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

Neck Evolution With Ovation in Spain

This study is testing the safety and effectiveness of a new device called the Ovation Alto Endograft for treating abdominal aortic aneurysms in patients who need surgery.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: DGM Vascular (Research network)
• Locations: 9 sites (Palma de Mallorca, Balearic Islands and 8 other locations)
• Trial ID: NCT05823519 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with de novo infrarenal or aorto-iliac AAA who are eligible for endovascular repair with the Ovation Alto Endograft.

Not a fit: Patients currently participating in other studies with the same device or endpoint, or those with known allergies to device components, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of the Ovation Alto Endograft's long-term safety and effectiveness, potentially improving patient outcomes in AAA treatment.

How similar studies have performed: While this study builds on existing knowledge of endovascular repair techniques, it specifically focuses on the Ovation Alto Endograft, which may provide new insights into its long-term performance.

Eligibility criteria

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 this trial is running

Palma de Mallorca, Balearic Islands and 8 other locations

• 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)
• Hospital Universitario De Cabueñes — Gijón, Principality of Asturias, Spain (Recruiting)
• Hospital De La Santa Creu I Sant Pau — Barcelona, Spain (Recruiting)
• Hospital Universitario Germans Trias i Pujol — Barcelona, Spain (Recruiting)

Study contacts

• Principal investigator: Manuel Alonso Pérez, MD — Hospital Universitario Central de Asturias
• Study coordinator: Manuel Alonso Pérez, MD

Conditions Abdominal Aortic Aneurysm; Alto Endograft