ALTo endogrAft Italian Registry

Launched by GIANMARCO DE DONATO · Feb 8, 2022

Keywords

ClinConnect Summary

The ALTo endogrAft Italian Registry is a clinical trial aimed at evaluating the safety and effectiveness of a specific treatment called the ALTO stent graft for patients with an abdominal aortic aneurysm (AAA). An AAA is a bulge in the large blood vessel that supplies blood to the body, which can be life-threatening if it breaks. This trial is looking at the results of the treatment during and after surgery to see how well it works over time.

To participate in this study, patients must be at least 18 years old and are scheduled for a planned (not emergency) surgery to repair their AAA using the ALTO device. Participants will need to agree to follow-up appointments to monitor their health after the procedure. It's important to note that people who have had urgent surgeries, certain health conditions, or a history of severe reactions to contrast dye used in imaging tests may not be eligible. By joining this study, participants can contribute valuable information to help improve AAA treatment outcomes for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Elective AAA patients that should be treated by standard EVAR, according to Endologix Alto endograft device's Instructions For Use;
• • Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study;
• • Patient is \>18 years old;
• • Patient, or their legal representative, understands the nature of the procedure and provides written informed consent, prior to enrollment in the study.
• Exclusion Criteria:
• • EVAR performed in Urgent/Emergent setting;
• • Patients treated outside Endologix Alto endograft device's Instructions For Use;
• • Patients refusing treatment;
• • Patients for whom antiplatelet therapy, anticoagulants or antihypertensive drug are contraindicated;
• • Patients with a history of prior life-threatening contrast medium reaction;
• • Life expectancy of less than follow-up period.
• • AAA: abdominal aortic aneurysm; EVAR: abdominal endovascular aneurysm