ALTO endograft implantation: Implantantion of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms
Study 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 Aortic Aneurysm repair in a multicentric consecutive experience.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Technical success — 90 days correct graft deployment without any unintentional occlusion of the aortic visceral branches and/or both hypogastric arteries, with aneurysm exclusion confirmed by the intraoperative angiography, without signs of type I/III endoleak a conversion to open surgery.
Technical success — 1 year correct graft deployment without any unintentional occlusion of the aortic visceral branches and/or both hypogastric arteries, with aneurysm exclusion confirmed by the intraoperative angiography, without signs of type I/III endoleak a conversion to open surgery.
Technical success — 5 years correct graft deployment without any unintentional occlusion of the aortic visceral branches and/or both hypogastric arteries, with aneurysm exclusion confirmed by the intraoperative angiography, without signs of type I/III endoleak a conversion to open surgery.
Clinical success — 90 days Successful deployment of the endovascular device at the intended location without death as a result of aneurysm-related treatment, type I or III endoleak, or graft infection or thrombosis, aneurysm expansion (\>5 mm), aneurysm rupture, or conversion to open repair. Moreover, the presence of graft dilatation of 20% or more by diameter, graft migration, or a failure of device integrity.
Clinical success — 1 year Successful deployment of the endovascular device at the intended location without death as a result of aneurysm-related treatment, type I or III endoleak, or graft infection or thrombosis, aneurysm expansion (\>5 mm), aneurysm rupture, or conversion to open repair. Moreover, the presence of graft dilatation of 20% or more by diameter, graft migration, or a failure of device integrity.
Clinical success — 5 years Successful deployment of the endovascular device at the intended location without death as a result of aneurysm-related treatment, type I or III endoleak, or graft infection or thrombosis, aneurysm expansion (\>5 mm), aneurysm rupture, or conversion to open repair. Moreover, the presence of graft dilatation of 20% or more by diameter, graft migration, or a failure of device integrity.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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