Status:
RECRUITING
ALTo endogrAft Italian Registry
Lead Sponsor:
Gianmarco de Donato
Collaborating Sponsors:
University of Roma La Sapienza
University of Siena
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Brief Summary
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 Aor...
Detailed Description
Thirty years ago, Juan Parodi developed the first prototype of endograft for Endovascular Aneurysm Repair, a handmade device made of a tube-shaped aorto-aortic graft sutured at each end to a balloon-e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05234892
Start Date
January 1 2022
End Date
December 31 2028
Last Update
July 20 2023
Active Locations (2)
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1
University La Sapienza of Rome
Rome, Italy, 00185
2
University of Siena
Siena, Italy, 53100