JMIR Publications

ABSTRACT

Background:

Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for Abdominal Aortic Aneurysm (AAA) by a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020 the re-designed Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE mark approval.

Objective:

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

Methods:

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. Full data sets and cross-sectional images of contrast CT scan performed before EVAR, at first post-operative month, at 30 ± 6 months and at 5 years follow-up interval will be reported in the central database for a centralized core lab review of morphological changes. 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. The following secondary endpoints will be also addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month, and 5-year follow-up, any potential role of patients’ baseline characteristics, valuated on preoperative Computed Tomography Angiography, and of device configuration (number of component) on primary endpoint.

Results:

The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. In itinere updated will be shared at 1-year follow-up and at 3-5 years follow-up.

Conclusions:

The results from this registry could validate the safety and effectiveness of new design of the device under investigation. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on label. Clinical Trial: ALTo endogrAft Italian Registry (ALTAIR) Clinicaltrial.gov Identifier: NCT05234892 URL: https://clinicaltrials.gov/ct2/results?cond=&term=NCT05234892&cntry=&state=&city=&dist=