No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
300 (estimated)
Sponsor
Gianmarco de Donato · Other
Who this trial is looking for
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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.
Trial Locations
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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…
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
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