JMIR Publications

ABSTRACT

Background:

Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAA), progressive improvements in results have been achieved. However, conventional bifurcated stentgrafts have been proven to have a not negligible risk of failure and secondary intervention, principally due to lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA unibody device (Endologix; Irvine, CA – USA), providing a completely different sealing and fixation features respect to conventional devices, seems to overcome those limitations.

Objective:

To evaluate intraoperative, peri-operative and post-operative results in patients treated with AFX 2 Endovascular AAA endograft for elective AAA repair in a large cohort of consecutive patients.

Methods:

All eligible EVAR patients will be included in this observational, multicenter, prospective, non-randomized study. The number of patients to be enrolled is 500.

Results:

The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endopoints 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 and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020 and the estimated study completion date is December 2025.

Conclusions:

This study will provide verified real-world data on AAA treated by AFX 2 endograft and followed for a long time interval.