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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vascutek Ltd.
ClinicalTrials.gov Identifier:
NCT01744119
First received: November 29, 2012
Last updated: March 2, 2015
Last verified: March 2015
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Australia
Geelong Regional Vascular Service
Geelong, Australia, 3220
Hollywood, Royal Perth
Perth, Australia, WA 6000
Royal Perth Hospital
Perth, Australia, 6000
France
Clinique Guillaume De Varye
Saint Doulchard, France, 18230
Germany
DRK Kliniken Mark Brandenburg
Berlin, Germany, 13359
Dresden-Friedrichstadt
Dresden, Germany, 0167
Klinikum Grosshadern
Munich, Germany, 81377
Italy
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
Spain
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.
  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: March 2, 2015
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on July 29, 2015