Abdominal Aortic Aneurysm Clinical Trial
Official title:
A Study to Assess the Acute Technical Success 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
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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