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The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anacondaâ„¢ 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 Anacondaâ„¢, the world's next generation of AAA stent graft systems. Intuitive and of a modular design, Anacondaâ„¢ 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal Aortic Aneurysm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascutek Anacondaâ„¢ Stent Graft System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 months |
| Graft patency | Data will be collected and analysed on endoleak exclusion and graft migration rates | 60 months |
| Exclusion of aneurysm | 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with a CE-Marked Vascutek Anacondaâ„¢ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalcross Private Hospital | Killara | New South Wales | 2071 | Australia | ||
| Newcastle Private Medical Suites |
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| Newcastle |
| New South Wales |
| NSW 2305 |
| Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| The Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Geelong Regional Vascular Service | Geelong | 3220 | Australia |
| Royal Perth Hospital | Perth | 6000 | Australia |
| Hollywood, Royal Perth | Perth | WA 6000 | Australia |
| Clinique Guillaume De Varye | Saint-Doulchard | 18230 | France |
| DRK Kliniken Mark Brandenburg | Berlin | 13359 | Germany |
| Dresden-Friedrichstadt | Dresden | 0167 | Germany |
| Klinikum Grosshadern | Munich | 81377 | Germany |
| San Orsola - Bologna University | Bologna | Italy |
| University federico II | Naples | 80138 | Italy |
| Guglielmo da Saliceto | Piacenza | Italy |
| Casa di Cura Nuova Itor | Roma | 00158 | Italy |
| Christchurch Hospital, CDHB | Christchurch | 8011 | New Zealand |
| Waikato Hospital | Hamilton | 3204 | New Zealand |
| Hospital Universitario Madrid Monteprincipe | Madrid | 28660 | Spain |
| Royal Derby Hospital | Derby | DE22 3NE | United Kingdom |
| Gartnavel General Hospital | Glasgow | G12 0YN | United Kingdom |
| Wishaw General Hospital | Wishaw | ML2 0DP | United Kingdom |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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