NCT01744119

Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry

Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 318 (actual)
• Sponsor: Vascutek Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Vascutek Anaconda™ Stent Graft System

Timeline

• Start date: 2005-04-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-12-06
• Last updated: 2016-05-24

Locations

21 sites across 7 countries: Australia, France, Germany, Italy, New Zealand, Spain, United Kingdom