Abdominal Aortic Aneurysm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEVascutek Anaconda™ Stent Graft System
Sponsors
Vascutek Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is implanted with Anaconda™ Stent Graft System
Exclusion criteria
* Ruptured or symptomatic aneurysm * Juxta or Suprarenal extension of aneurysm * Clinically serious concomitant medical disease or infection * Need to sacrifice both Internal Iliac Arteries due to aneurysmal dilatation * Connective Tissue Disease (Marfan's Syndrome) * ASA Rating of Grade IV or V * Known allergy to Nitinol, Polyester or contrast medium * Excessive tortuosity of access vessels (femoral or iliac arteries) * Patients with aneurysm neck lengths of less than 15mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exclusion of aneurysm | 60 months | — |
| Evaluation of graft performance | 60 months | 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. |
| Graft patency | 60 months | Data will be collected and analysed on endoleak exclusion and graft migration rates |
Countries
Australia, France, Germany, Italy, New Zealand, Spain, United Kingdom
Outcome results
None listed