ALTo endogrAft Italian Registry

Recruiting now

Conditions studied: Abdominal Aortic Aneurysm

In brief

The aim of present study is to evaluate intraoperative, peri-operative, and post-operative results in patients treated by the ALTO stent graft (Endologix Inc. Irvine, Calif) for elective Abdominal Aortic Aneurysm repair in a multicentric consecutive experience.

Key facts

Study ID

NCT05234892

Run by

Gianmarco de Donato

People needed

300

Starts

2022-01-01

Expected to finish

2028-12-31

Last updated by the study team

2023-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University La Sapienza of Rome — Rome, Italy (enrolling)
• University of Siena — Siena, Italy (enrolling)

Full record on ClinicalTrials.gov

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