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.
Study Type
OBSERVATIONAL
Enrollment
318
Dalcross Private Hospital
Killara, New South Wales, Australia
Newcastle Private Medical Suites
Newcastle, New South Wales, Australia
Evaluation of graft performance
Data will be collected and analysed on system insertion and difficulty during deployment. Efficiency of the magnet system including magnet selection, ease of use and removal of magnet guidewire will also be evaluated.
Time frame: 60 months
Graft patency
Data will be collected and analysed on endoleak exclusion and graft migration rates
Time frame: 60 months
Exclusion of aneurysm
Time frame: 60 months
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Westmead Hospital
Westmead, New South Wales, Australia
The Austin Hospital
Heidelberg, Victoria, Australia
Geelong Regional Vascular Service
Geelong, Australia
Royal Perth Hospital
Perth, Australia
Hollywood, Royal Perth
Perth, Australia
Clinique Guillaume De Varye
Saint-Doulchard, France
DRK Kliniken Mark Brandenburg
Berlin, Germany
Dresden-Friedrichstadt
Dresden, Germany
...and 11 more locations