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

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01744119
• Other study ID #: ANA-PMS001
• Status: Terminated
• Phase: N/A
• First received: November 29, 2012
• Last updated: May 23, 2016
• Start date: April 2005
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Vascutek Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 318
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Vascutek Anaconda™ Stent Graft System

Locations

Country	Name	City	State
Australia	Geelong Regional Vascular Service	Geelong
Australia	The Austin Hospital	Heidelberg	Victoria
Australia	Dalcross Private Hospital	Killara	New South Wales
Australia	Newcastle Private Medical Suites	Newcastle	New South Wales
Australia	Hollywood, Royal Perth	Perth
Australia	Royal Perth Hospital	Perth
Australia	Westmead Hospital	Westmead	New South Wales
France	Clinique Guillaume De Varye	Saint Doulchard
Germany	DRK Kliniken Mark Brandenburg	Berlin
Germany	Dresden-Friedrichstadt	Dresden
Germany	Klinikum Grosshadern	Munich
Italy	San Orsola - Bologna University	Bologna
Italy	University federico II	Naples
Italy	Guglielmo da Saliceto	Piacenza
Italy	Casa di Cura Nuova Itor	Roma
New Zealand	Christchurch Hospital, CDHB	Christchurch
New Zealand	Waikato Hospital	Hamilton
Spain	Hospital Universitario Madrid Monteprincipe	Madrid
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	Gartnavel General Hospital	Glasgow
United Kingdom	Wishaw General Hospital	Wishaw

Sponsors (1)

Lead Sponsor	Collaborator
Vascutek Ltd.

Countries where clinical trial is conducted

Australia,  France,  Germany,  Italy,  New Zealand,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of graft performance	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.	60 months	No
Primary	Graft patency	Data will be collected and analysed on endoleak exclusion and graft migration rates	60 months	No
Primary	Exclusion of aneurysm		60 months	No