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

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Abdominal aortic aneurysm
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Brief Title

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

Official Title

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

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.

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

Primary Outcome

Evaluation of graft performance

Condition

Abdominal Aortic Aneurysm

Intervention

Vascutek Anaconda™ Stent Graft System

Study Arms / Comparison Groups

 Abdominal Aortic Aneurysm
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

318

Start Date

April 2005

Completion Date

May 2016

Primary Completion Date

May 2016

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT01744119

Organization ID

ANA-PMS001

Responsible Party

Sponsor

Study Sponsor

Vascutek Ltd.

Study Sponsor

, ,

Verification Date

May 2016