Last updated on April 2018

Global Fenestrated Anaconda Clinical sTudy


Brief description of study

This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda system, and is essentially a post-market study. The Vascutek Fenestrated Anaconda system is a custom made device used for the treatment of Abdominal Aortic Aneurysm.

Detailed Study Description

Abdominal Aortic Aneurysm (AAA) is a life threatening disease. Endovascular repair of infrarenal abdominal aortic aneurysms (EVAR) has replaced open surgical repair as the standard of care treatment for most patients. Endovascular repair offers several benefits over open surgical repair, including: less invasive procedure, faster recovery, lower morbidity and lower early post-operative mortality. The configuration of vascular anatomy is important to the successful placement and subsequent performance of infrarenal EVAR devices. In particular aortic neck angulation and length are important for the success of EVAR. Challenging necks with an aortic diameter 28 mm, angulation 60, length <10mm, circumferential thrombus, reversed tapered configuration or neck with bulging, make it more difficult to oppose the endograft to the aortic wall and are related to an increased risk of type Ia endoleak and reinterventions. In order to overcome these issues, fenestrated and branched stent grafts have been developed. Fenestrated and branched endovascular aneurysm repair is now a routinely utilised procedure in the treatment of complex aortic aneurysm anatomy, especially in patients unsuitable for open surgical repair.

The Fenestrated Anaconda device (Vascutek Ltd, Glasgow, Scotland, UK) has been commercially available since 2010. The Fenestrated Anaconda device has potential advantages over other FEVAR devices, since it can be repositioned after deployment, has a magnet-assisted limb cannulation, and the device contains less metal, allowing a better view of the radiological markers on the device during intra-operative imaging. Additionally, the potential to position fenestrations anywhere in the main body is unrestricted due to the absence of other stent structures.

This prospective, real world study of the Fenestrated Anaconda device will provide insight into both the short and long term clinical outcomes of the device. An attempt will be made to identify predictors of success or failure, and this study will help to identify patients that are likely to benefit from repair and improve results. The effect of FEVAR on post-operative patient reported quality of life will be assessed. In addition, the study will provide insight into the potential decline in renal function after FEVAR, a well-known concern after both EVAR and FEVAR.

Clinical Study Identifier: NCT03180996

Contact Investigators or Research Sites near you

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Sarah Thomas

Epworth Richmond Private Hospital
Melbourne, Australia
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Sarah Thomas

Hollywood Medical Centre
Perth, Australia
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Sarah Thomas

Wilhelminenspital
Vienna, Austria
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Sarah Thomas

Peter Lougheed Centre
Calgary, AB Canada
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Sarah Thomas

CHU Bordeaux
Bordeaux, France
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Sarah Thomas

Policlinico S. Orsola Malpighi
Bologna, Italy
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Sarah Thomas

Rijnstate Hospital
Arnhem, Netherlands
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Sarah Thomas

Medisch Spectrum Twente (MST)
Enschede, Netherlands
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Sarah Thomas

Universitair Medisch Centrum Groningen (UMCG)
Groningen, Netherlands
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Sarah Thomas

Antonius Ziekenhuis
Nieuwegein, Netherlands
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Sarah Thomas

Freeman Hospital
Newcastle upon Tyne, United Kingdom
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Sarah Thomas

Frimley Park Hospital
Frimley, Camberley, United Kingdom
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Sarah Thomas

Imperial College, St Mary's Hospital
London, United Kingdom
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Sarah Thomas

Uniklinik K ln
Köln, Germany
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