Abdominal Aortic Aneurysms (AAA) Clinical Trial
This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft in patients with a short infrarenal neck of <15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated Stent Graft and for whom a customised medical device is required.
AnacondaTM Custom Fenestrated Devices (CFD) are designed for the endovascular repair of
abdominal aortic aneurysms (AAA) for cases where the aneurysm extends superiorly very close
to or involving the renal arteries, leaving insufficient neck length for infrarenal device
sealing. The non-CE marked devices are custom designed based on CT scan data of the
patient's aorta and regulated in accordance with the Medical Device Directive (93/42/EEC)
and associated country specific regulations as applicable.
The proximal end of the AnacondaTM fenestrated body device is positioned suprarenally, where
it seals and fixates in the vessel by means of rings comprised of multiple turns of fine
nitinol wire, attached to the fabric with polyester sutures, creating a self-expanding stent
which provides a conformable seal with the vessel wall and assists in anchoring of the
device. Nitinol hooks provide secure fixation within the suprarenal aorta. The saddle shape
of the rings allows the superior mesenteric artery (SMA) or celiac artery to be accommodated
in the valley of the top ring saddle in some cases.
The objective of the registry is to provide long term (5 year) safety and effectiveness data
of all patients who consent to their data to be used in the registry. This data aims to
demonstrate that the Vascutek AnacondaTM Custom Fenestrated Stent Graft is safe and
effective in patients with a short infrarenal neck of <15mm or juxta-renal abdominal aortic
aneurysms who, in the opinion of the treating physician, are anatomically suitable for the
AnacondaTM Custom Fenestrated Stent Graft.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00507559 -
The Pivotal Study of the Aptus Endovascular AAA Repair System
|
N/A |