Neck Evolution With Ovation in Spain

Launched by DGM VASCULAR · Apr 10, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Neck Evolution With Ovation in Spain" is studying the safety and effectiveness of a specific medical device called the Ovation Alto Endograft, which is used to treat a condition known as Abdominal Aortic Aneurysm (AAA). This trial aims to gather information about how well this device works and whether it helps maintain a stable neck diameter in the aorta, which is important for patient safety over time. The study will enroll between 50 to 120 participants who will be monitored closely after their procedure and followed up at various points for up to three years.

To be eligible for the trial, participants need to be at least 18 years old and must have given their consent for their information to be shared. They should have a specific type of AAA that allows for treatment with the Ovation Alto Endograft. However, individuals currently involved in other clinical studies or who have allergies to the device components cannot participate. By joining this study, participants can expect regular follow-ups to help researchers understand how well the device works in real-life situations.

Gender

ALL

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).