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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01744119
Recruitment Status : Terminated
First Posted : December 6, 2012
Last Update Posted : May 24, 2016
Information provided by (Responsible Party):
Vascutek Ltd.

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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm 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
Actual Enrollment : 318 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
Study Start Date : April 2005
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Evaluation of graft performance [ Time Frame: 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.

  2. Graft patency [ Time Frame: 60 months ]
    Data will be collected and analysed on endoleak exclusion and graft migration rates

  3. Exclusion of aneurysm [ Time Frame: 60 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01744119

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

Responsible Party: Vascutek Ltd. Identifier: NCT01744119     History of Changes
Other Study ID Numbers: ANA-PMS001
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases