| NCT ID | NCT05823519 |
| Status | Recruiting |
| Phase | — |
| Sponsor | DGM Vascular |
| Condition | Abdominal Aortic Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2024-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2022-06-01 with a primary completion date of 2024-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Manuel Alonso Pérez, MD
PRINCIPAL INVESTIGATOR
Hospital Universitario Central de Asturias
Frequently Asked Questions
Who can join the NCT05823519 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Abdominal Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05823519 currently recruiting?
Yes, NCT05823519 is actively recruiting participants. Contact the research team at manuel.alonsop@sespa.es for enrollment information.
Where is the NCT05823519 trial being conducted?
This trial is being conducted at Palma de Mallorca, Spain, Girona, Spain, Barakaldo, Spain, Burgos, Spain and 5 additional locations.
Who is sponsoring the NCT05823519 clinical trial?
NCT05823519 is sponsored by DGM Vascular. The principal investigator is Manuel Alonso Pérez, MD at Hospital Universitario Central de Asturias. The trial plans to enroll 120 participants.