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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Vascutek Ltd.
Sponsor:
Information provided by (Responsible Party):
Vascutek Ltd.
ClinicalTrials.gov Identifier:
NCT01744119
First received: November 29, 2012
Last updated: November 14, 2014
Last verified: November 2014

November 29, 2012
November 14, 2014
April 2005
April 2017   (final data collection date for primary outcome measure)
  • 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 ]
  • Evaluation of graft performance [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Data will be collected and analysed on system insertion, difficulty during deployment and efficiency of magnet system
  • 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 ]
Complete list of historical versions of study NCT01744119 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Abdominal Aortic Aneurysm
Device: Vascutek Anaconda™ Stent Graft System
Abdominal Aortic Aneurysm
Intervention: Device: Vascutek Anaconda™ Stent Graft System
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
April 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Australia,   France,   Germany,   Italy,   New Zealand,   Spain,   United Kingdom
 
NCT01744119
ANA-PMS001
Not Provided
Vascutek Ltd.
Vascutek Ltd.
Not Provided
Not Provided
Vascutek Ltd.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP