Clinical trial NCT01744119: Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry
Official title: Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Evaluation of graft performance
timeFrame: 60 months
measure: Graft patency
timeFrame: 60 months
measure: Exclusion of aneurysm
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Killara
country: Australia
facility: Dalcross Private Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: Newcastle Private Medical Suites
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Heidelberg
country: Australia
facility: The Austin Hospital
state: Victoria
city: Geelong
country: Australia
facility: Geelong Regional Vascular Service
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Perth
country: Australia
facility: Hollywood, Royal Perth
city: Saint Doulchard
country: France
facility: Clinique Guillaume De Varye
city: Berlin
country: Germany
facility: DRK Kliniken Mark Brandenburg
city: Dresden
country: Germany
facility: Dresden-Friedrichstadt
city: Munich
country: Germany
facility: Klinikum Grosshadern
city: Bologna
country: Italy
facility: San Orsola - Bologna University
city: Naples
country: Italy
facility: University federico II
city: Piacenza
country: Italy
facility: Guglielmo da Saliceto
city: Roma
country: Italy
facility: Casa di Cura Nuova Itor
city: Christchurch
country: New Zealand
facility: Christchurch Hospital, CDHB
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Monteprincipe
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
city: Wishaw
country: United Kingdom
facility: Wishaw General Hospital
Study officials:
References: