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

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

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.

Study Overview

• Status: Terminated
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Vascutek Anaconda™ Stent Graft System

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.

• Study Type: Observational
• Enrollment (Actual): 318

Contacts and Locations

Study Locations

• Australia
  • Geelong, Australia, 3220
    • Geelong Regional Vascular Service
  • Perth, Australia, 6000
    • Royal Perth Hospital
  • Perth, Australia, WA 6000
    • Hollywood, Royal Perth
  • New South Wales
    • Killara, New South Wales, Australia, 2071
      • Dalcross Private Hospital
    • Newcastle, New South Wales, Australia, NSW 2305
      • Newcastle Private Medical Suites
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • The Austin Hospital
• France
  • Saint Doulchard, France, 18230
    • Clinique Guillaume De Varye
• Germany
  • Berlin, Germany, 13359
    • DRK Kliniken Mark Brandenburg
  • Dresden, Germany, 0167
    • Dresden-Friedrichstadt
  • Munich, Germany, 81377
    • Klinikum Großhadern
• Italy
  • Bologna, Italy
    • San Orsola - Bologna University
  • Naples, Italy, 80138
    • University Federico II
  • Piacenza, Italy
    • Guglielmo da Saliceto
  • Roma, Italy, 00158
    • Casa di Cura Nuova Itor
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital, CDHB
  • Hamilton, New Zealand, 3204
    • Waikato Hospital
• Spain
  • Madrid, Spain, 28660
    • Hospital Universitario Madrid Montepríncipe
• United Kingdom
  • Derby, United Kingdom, DE22 3NE
    • Royal Derby Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Gartnavel General Hospital
  • Wishaw, United Kingdom, ML2 0DP
    • Wishaw General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with a CE-Marked Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Abdominal Aortic Aneurysm	Device: Vascutek Anaconda™ Stent Graft System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Vascutek Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (ESTIMATE): December 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 24, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: ANA-PMS001