To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac arteries.
The Aorfix™ Stent Graft is currently a CE-marked product indicated for AAA where the angle of the aneurysm is \<65o. The objective of this study is to evaluate the safety and performance of the bifurcated Aorfix™ Stent Graft in the treatment of infrarenal abdominal aortic aneurysms and aorto-iliac aneurysms, in infrarenal necks angulated \> 60o (between 60 to 90 degrees) as measured by 3-dimensional reconstruction in order to widen the indication. The investigation is a prospective open label, single arm, multi-centre clinical study. The study group will consist of 25 evaluable participants. In order to account for patients lost to follow up (estimated at approximately 20%) up to 30 patients will be enrolled in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Endovascular treatment of AAA using the Aorfix™ Stent Graft and Delivery System
2 Interni Klinika; General University Hospital
Prague, Czechia
Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster
Münster, Germany
Department of Interventional Radiology, University School of Medicine
Lublin, Poland
Vascular Surgery Division, Thoracic Institute, Hospital Clinic, University of Barcelona
Barcelona, Spain
The primary endpoints are acute technical success, initial performance and safety at 1-month follow up.
Time frame: 1-month post-procedure
Secondary endpoints will examine recovery factors: operative time, ICU duration, blood loss, days to normal diet, days to discharge, days to ambulation, freedom from non-clinical events, need for secondary procedure and conversion to uni-iliac.
Time frame: 6-months post-procedure
As well as safety at 6-month follow-up as measured by serious adverse events that occur up to 6-months post-procedure.
Time frame: 6-months post-procedure
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Belfast City Hospital Trust
Belfast, United Kingdom
Freeman Hospital; Main X-Ray
Newcastle upon Tyne, United Kingdom