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

V

Vascutek

Status

Terminated

Conditions

Abdominal Aortic Aneurysm

Treatments

Device: Vascutek Anaconda™ Stent Graft System

Study type

Observational

Funder types

Industry

Identifiers

NCT01744119
ANA-PMS001

Details and patient eligibility

About

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.

Full 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.

Enrollment

318 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

318 participants in 1 patient group

Abdominal Aortic Aneurysm
Treatment:
Device: Vascutek Anaconda™ Stent Graft System

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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