Clinical trial NCT01826344: The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abdominal Aortic Aneurysms (AAA)
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-08
Enrollment: 628
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 with a short infrarenal neck of \<15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated Stent Graft and for whom a customised medical device is required.

Brief summary: This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft in patients with a short infrarenal neck of \<15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated Stent Graft and for whom a customised medical device is required.

Detailed description: AnacondaTM Custom Fenestrated Devices (CFD) are designed for the endovascular repair of abdominal aortic aneurysms (AAA) for cases where the aneurysm extends superiorly very close to or involving the renal arteries, leaving insufficient neck length for infrarenal device sealing. The non-CE marked devices are custom designed based on CT scan data of the patient's aorta and regulated in accordance with the Medical Device Directive (93/42/EEC) and associated country specific regulations as applicable.

The proximal end of the AnacondaTM fenestrated body device is positioned suprarenally, where it seals and fixates in the vessel by means of rings comprised of multiple turns of fine nitinol wire, attached to the fabric with polyester sutures, creating a self-expanding stent which provides a conformable seal with the vessel wall and assists in anchoring of the device. Nitinol hooks provide secure fixation within the suprarenal aorta. The saddle shape of the rings allows the superior mesenteric artery (SMA) or celiac artery to be accommodated in the valley of the top ring saddle in some cases.

The objective of the registry is to provide long term (5 year) safety and effectiveness data of all patients who consent to their data to be used in the registry. This data aims to demonstrate that the Vascutek AnacondaTM Custom Fenestrated Stent Graft is safe and effective in patients with a short infrarenal neck of \<15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated Stent Graft.

Eligibility criteria: Inclusion Criteria:

A patient with juxta renal abdominal aortic aneurysms (AAA) who, in the opinion of the treating physician, is anatomically suitable for the Anaconda Fenestrated Graft and for whom a customised medical device is required.

Exclusion Criteria:

1. Ruptured or symptomatic aneurysm
2. Clinically significant concomitant medical disease or infection
3. Connective Tissue Disease (e.g. Marfan's Syndrome)
4. Known allergy to nitinol, polyester or contrast medium
5. Excessive tortuosity of access vessels (femoral or iliac arteries)
6. Landing zone of less than 10mm in the visceral segment of the aorta
7. Inability to comply to follow up protocol
8. Access vessels less than 6mm in diameter
9. Diseased or excessively tortuous access to target vessels
10. Target vessels of less than 5mm in calibre
11. Excessive calcification or thrombus at the intended landing zone which could affect sealing

Primary outcomes:
measure: To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft
timeFrame: For 5 years post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Kaiser Franz Josef Spital
city: Vienna
country: Austria
facility: Krankenhaus Hietzing
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Brussels
country: Belgium
facility: St Luc Brussels
city: Brussels
country: Belgium
facility: University Hospital, Brussels
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
city: Roeselare
country: Belgium
facility: H.-Hartziekenhuis Roeselare-Menen
city: Calgary
country: Canada
facility: Peter Lougheed Centre
city: Halifax
country: Canada
facility: QE2 Hospital
city: London, Ontario
country: Canada
facility: London Health Sciences Centre
city: Montreal
country: Canada
facility: Royal Victoria Hospital
city: Ottawa
country: Canada
facility: The Ottawa Hospital
city: St Johns
country: Canada
facility: St Clare's Mercy Hospital
city: Toronto
country: Canada
facility: Toronto General Hospital
city: Winnipeg
country: Canada
facility: Health Science Centre
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Creteil
country: France
facility: CHU Henri Mondor
city: Draguignan
country: France
facility: Chirurgien Vasculaire
city: Nancy
country: France
facility: Clinique Ambrose Paré
city: Paris
country: France
facility: La Pitie
city: Paris
country: France
facility: Le Plessis Robinson
city: Tours
country: France
facility: CHU Tours
city: Aachen
country: Germany
facility: Luisenhospital - Aachen
city: Aachen
country: Germany
facility: University Hospital Aachen
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bremen
country: Germany
facility: Red Cross hospital clinic
city: Cologne
country: Germany
facility: University of Cologne
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Hochst
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Freital
country: Germany
facility: Krankenhaus Freital
city: Goettingen
country: Germany
facility: Chirurgie am Waldweg
city: Groningen
country: Germany
facility: University of Groningen
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hamm
country: Germany
facility: Medical Care Centre for Vascular Diseases
city: Kevelaer
country: Germany
facility: Marienhospital
city: Lingen
country: Germany
facility: Bonifacius Hospital
city: Munich
country: Germany
facility: University Hospital
city: Neustrelitz
country: Germany
facility: DRK Krankenhaus Neustrelitz
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Bruder
city: Regensburg
country: Germany
facility: University Hospital
city: Solingen
country: Germany
facility: Klinikum Solingen
city: Witten
country: Germany
facility: Marien-Hospital Witten
city: Bologna
country: Italy
facility: University of Bologna
city: Nuoro
country: Italy
facility: Ospedale San Francesco
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel
city: Rome
country: Italy
facility: San Filippo Neri Hospital
city: Monaco
country: Monaco
facility: Centre Cardio Thoracique
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Rotterdam
country: Netherlands
facility: Erasmus University
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
city: San Sebastian
country: Spain
facility: Hospital Donostia
city: Uppsala
country: Sweden
facility: Uppsala University
city: Bern
country: Switzerland
facility: University Hospital Bern
city: Chur
country: Switzerland
facility: Kantonsspital Graubunden
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Glasgow
country: United Kingdom
facility: Western Infirmary/Gartnavel
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Imperial (St Mary's / Charing X) Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: The Royal Free Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
References: