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

This study is currently recruiting participants.
Verified February 2014 by Vascutek Ltd.
Sponsor:
Information provided by (Responsible Party):
Vascutek Ltd.
ClinicalTrials.gov Identifier:
NCT01744119
First received: November 29, 2012
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair

Resource links provided by NLM:


Further study details as provided by Vascutek Ltd.:

Primary Outcome Measures:
  • Evaluation of graft performance [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Data will be collected and analysed on endoleak exclusion and graft migration rates

  • Exclusion of aneurysm [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2005
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744119

Locations
Australia, New South Wales
Dalcross Private Hospital Recruiting
Killara, New South Wales, Australia, 2071
Contact: Dr Richard Harris    (02) 9932 6600      
Principal Investigator: Dr Richard Harris         
Newcastle Private Medical Suites Recruiting
Newcastle, New South Wales, Australia, NSW 2305
Contact: Dr Paul Myers    (02) 4952 5911      
Principal Investigator: Dr Paul Myers         
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Dr John Fletcher    (02)9845 5555      
Principal Investigator: Dr John Fletcher         
Australia, Victoria
The Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Dr Gary Fell    (03)9496 5000      
Principal Investigator: Dr Gary Fell         
Australia
Geelong Regional Vascular Service Recruiting
Geelong, Australia, 3220
Contact: Dr David Neale McClure    (03) 5229 0024      
Principal Investigator: Dr David Neale McClure         
Royal Perth Hospital Recruiting
Perth, Australia, 6000
Contact: Dr Bibombe Patrice Mwipatayi    (08)9224 2244      
Principal Investigator: Dr Bibombe Patrice Mwipatayi         
Hollywood, Royal Perth Recruiting
Perth, Australia, WA 6000
Contact: Dr Kishore Sieunarine    (08)9224 2244      
Principal Investigator: Dr Kishore Sieunarine         
France
Clinique Guillaume De Varye Recruiting
Saint Doulchard, France, 18230
Contact: Dr Olivier Briand    0826 39 99 08      
Contact: Dr Darrieus         
Principal Investigator: Dr Olivier Briand         
Sub-Investigator: Dr Darrieus         
Germany
DRK Kliniken Mark Brandenburg Recruiting
Berlin, Germany, 13359
Contact: Dr Ingo Flessenkaemper    030 30356001      
Principal Investigator: Dr Ingo Flessenkaemper         
Dresden-Friedrichstadt Recruiting
Dresden, Germany, 0167
Contact: Dr Hans Florek    0351 480-0      
Principal Investigator: Dr Hans Florek         
Klinikum Grosshadern Recruiting
Munich, Germany, 81377
Contact: Dr Reinhard Kopp    089 5160-0      
Principal Investigator: Dr Reinhard Kopp         
Italy
San Orsola - Bologna University Recruiting
Bologna, Italy
Contact: Dr Antonio Freyrie    +39 051 2099507      
Principal Investigator: Dr Antonio Freyrie         
University federico II Recruiting
Naples, Italy, 80138
Contact: Dr Giancarlo Bracale    081 676799      
Principal Investigator: Dr Giancarlo Bracale         
Guglielmo da Saliceto Recruiting
Piacenza, Italy
Contact: Dr Ugo Ugolotti    0523 302366      
Principal Investigator: Dr Ugo Ugolotti         
Casa di Cura Nuova Itor Recruiting
Roma, Italy, 00158
Contact: Dr Sante Camilli    06 416021      
Principal Investigator: Dr Sante Camilli         
New Zealand
Christchurch Hospital, CDHB Recruiting
Christchurch, New Zealand, 8011
Contact: Dr David Lewis    (03) 364 0640      
Principal Investigator: Dr David Lewis         
Waikato Hospital Recruiting
Hamilton, New Zealand, 3204
Contact: Dr Thodur Vasudevan    (07) 839 8899      
Principal Investigator: Dr Thodur Vasudevan         
Spain
Hospital Universitario Madrid Monteprincipe Recruiting
Madrid, Spain, 28660
Contact: Dr Luis Izquierdo Lamoca    917 08 99 00      
Principal Investigator: Dr Luis Izquierdo Lamoca         
United Kingdom
Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Contact: Dr Peter Bungay    01332 340131      
Principal Investigator: Dr Peter Bungay         
Gartnavel General Hospital Recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Dr Richard Edwards    0141 211 3000      
Principal Investigator: Dr Richard Edwards         
Wishaw General Hospital Recruiting
Wishaw, United Kingdom, ML2 0DP
Contact: Dr Donald Reid    01698 361100      
Principal Investigator: Dr Donald Reid         
Sponsors and Collaborators
Vascutek Ltd.
  More Information

No publications provided

Responsible Party: Vascutek Ltd.
ClinicalTrials.gov Identifier: NCT01744119     History of Changes
Other Study ID Numbers: ANA-PMS001
Study First Received: November 29, 2012
Last Updated: February 11, 2014
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on April 15, 2014