Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 7, 2019
Date Accepted: Jan 26, 2020
Date Submitted to PubMed: Jun 24, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
AFX-2 - Less InVasive and faster EVAR (LIVE): the italian multicenter study about unibody endograft
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:
ENDPOINT: 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.
Conclusions:
This study will provide verified real-world data on AAA treated by AFX 2 endograft and followed for a long time interval.
Citation
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