Abdominal Aortic Aneurysm Clinical Trial
Official title:
Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-implantation.
Vascutek Limited, a world leader in the development of vascular grafts, has combined their
latest technological developments in polyester textile technology with unique endovascular
design features to produce Anaconda™, the world's next generation of AAA stent graft
systems. Intuitive and of a modular design, Anaconda™ is the only repositionable device
which also features exceptional flexibility. The modular design comprises bifurcate bodies,
iliac legs and aortic cuffs. Nitinol, an alloy of nickel and titanium, has self-expanding
properties and forms the top "ring-stent" of the bifurcate body section. The "ring stent" is
composed of multiple turns of Nitinol wire that provides significantly increased
"hoop-strength" enabling a conformable and secure haemostatic seal against the vessel wall
to be achieved. Nitinol hooks located adjacent to the "ring stent" anchor the graft in
position thus preventing graft migration. The iliac limbs are fully supported with Nitinol
and the bifurcate bodies feature a distal contra-lateral lumen Nitinol support, which in
conjunction with a unique intrinsic magnet guidewire system facilitates cannulation of the
bifurcate section.
The system is available in a wide range of sizes thus making it a flexible and adaptable
stent graft system with the potential to repair diverse patient anatomy.
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Observational Model: Cohort, Time Perspective: Prospective
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