The aim of present study is to evaluate intraoperative, peri-operative, and post-operative results in patients treated by the ALTO stent graft for elective AAA repair in a multicentric consecutive experience.
All consecutive eligible patients submitted to EVAR by Alto Endovascular AAA implantation will be included in analysis. Patients will be submitted to EVAR procedures on the basis of their own preferences, anatomical features, and operators experience.
An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years.
The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. Technical success was defined as the 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.
The following secondary endpoints will be also addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month, and 3-year follow-up, any potential role of baseline characteristics on primary endpoint.
This is a new concept device that, taking its cue from the excellent results of the previous platform (which was based on the same engineering philosophy), aims to increase the number of patients treatable with EVAR Standard up to (ideally) treat those who have not a suitable infrarenal aortic neck. Epidemiological data underline how this is the most fragile group of patients and also the ideal candidates for the use of this new prosthesis.
The current literature is not unambiguous in reserving endovascular treatment also for patients with Juxta- or Para-renal aneurysm, compared to open repair, the current gold standard.
The data expected from this research should confirm the further increase in indications.