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

Terminated

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Device: Vascutek Anaconda™ Stent Graft System

• Registration Number: NCT01744119
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-04
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 318

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abdominal Aortic Aneurysm	Vascutek Anaconda™ Stent Graft System	-

Primary Outcome Measures

Name	Time	Method
Evaluation of graft performance	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.
Graft patency	60 months	Data will be collected and analysed on endoleak exclusion and graft migration rates
Exclusion of aneurysm	60 months

Trial Locations

Locations (21)

Dalcross Private Hospital; 🇦🇺 Killara, New South Wales, Australia

Newcastle Private Medical Suites; 🇦🇺 Newcastle, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Royal Perth Hospital; 🇦🇺 Perth, Australia

The Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia

Geelong Regional Vascular Service; 🇦🇺 Geelong, Australia

DRK Kliniken Mark Brandenburg; 🇩🇪 Berlin, Germany

Hollywood, Royal Perth; 🇦🇺 Perth, Australia

Clinique Guillaume De Varye; 🇫🇷 Saint Doulchard, France

Dresden-Friedrichstadt; 🇩🇪 Dresden, Germany

Klinikum Grosshadern; 🇩🇪 Munich, Germany

San Orsola - Bologna University; 🇮🇹 Bologna, Italy

University federico II; 🇮🇹 Naples, Italy

Guglielmo da Saliceto; 🇮🇹 Piacenza, Italy

Hospital Universitario Madrid Monteprincipe; 🇪🇸 Madrid, Spain

Casa di Cura Nuova Itor; 🇮🇹 Roma, Italy

Christchurch Hospital, CDHB; 🇳🇿 Christchurch, New Zealand

Royal Derby Hospital; 🇬🇧 Derby, United Kingdom

Gartnavel General Hospital; 🇬🇧 Glasgow, United Kingdom

Wishaw General Hospital; 🇬🇧 Wishaw, United Kingdom

Waikato Hospital; 🇳🇿 Hamilton, New Zealand