The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
- Conditions
- Abdominal Aortic Aneurysms (AAA)
- Registration Number
- NCT01826344
- Lead Sponsor
- Vascutek Ltd.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 628
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.
- Ruptured or symptomatic aneurysm
- Clinically significant concomitant medical disease or infection
- Connective Tissue Disease (e.g. Marfan's Syndrome)
- Known allergy to nitinol, polyester or contrast medium
- Excessive tortuosity of access vessels (femoral or iliac arteries)
- Landing zone of less than 10mm in the visceral segment of the aorta
- Inability to comply to follow up protocol
- Access vessels less than 6mm in diameter
- Diseased or excessively tortuous access to target vessels
- Target vessels of less than 5mm in calibre
- Excessive calcification or thrombus at the intended landing zone which could affect sealing
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft For 5 years post-implant 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (70)
Maastricht University Medical Centre
🇳🇱Maastricht, Netherlands
Krankenhaus Hietzing
🇦🇹Vienna, Austria
Grand Hôpital de Charleroi
🇧🇪Charleroi, Belgium
Universitatsklinikum Freiburg
🇩🇪Freiburg, Germany
San Filippo Neri Hospital
🇮🇹Rome, Italy
Kaiser Franz Josef Spital
🇦🇹Vienna, Austria
Imelda Hospital
🇧🇪Bonheiden, Belgium
St Luc Brussels
🇧🇪Brussels, Belgium
H.-Hartziekenhuis Roeselare-Menen
🇧🇪Roeselare, Belgium
Peter Lougheed Centre
🇨🇦Calgary, Canada
University Hospital, Brussels
🇧🇪Brussels, Belgium
QE2 Hospital
🇨🇦Halifax, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Royal Victoria Hospital
🇨🇦Montreal, Canada
St Clare's Mercy Hospital
🇨🇦St Johns, Canada
The Ottawa Hospital
🇨🇦Ottawa, Canada
Toronto General Hospital
🇨🇦Toronto, Canada
Health Science Centre
🇨🇦Winnipeg, Canada
Hopital Pellegrin
🇫🇷Bordeaux, France
CHU Henri Mondor
🇫🇷Creteil, France
Clinique Ambrose Paré
🇫🇷Nancy, France
Chirurgien Vasculaire
🇫🇷Draguignan, France
CHU Tours
🇫🇷Tours, France
Le Plessis Robinson
🇫🇷Paris, France
La Pitie
🇫🇷Paris, France
Luisenhospital - Aachen
🇩🇪Aachen, Germany
University Hospital Aachen
🇩🇪Aachen, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Red Cross hospital clinic
🇩🇪Bremen, Germany
University of Cologne
🇩🇪Cologne, Germany
Klinikum Frankfurt Hochst
🇩🇪Frankfurt, Germany
Krankenhaus Freital
🇩🇪Freital, Germany
Chirurgie am Waldweg
🇩🇪Goettingen, Germany
University of Groningen
🇩🇪Groningen, Germany
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Medical Care Centre for Vascular Diseases
🇩🇪Hamm, Germany
Marienhospital
🇩🇪Kevelaer, Germany
Bonifacius Hospital
🇩🇪Lingen, Germany
DRK Krankenhaus Neustrelitz
🇩🇪Neustrelitz, Germany
Krankenhaus Barmherzige Bruder
🇩🇪Regensburg, Germany
University Hospital
🇩🇪Regensburg, Germany
Marien-Hospital Witten
🇩🇪Witten, Germany
Klinikum Solingen
🇩🇪Solingen, Germany
University of Bologna
🇮🇹Bologna, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel
🇮🇹Palermo, Italy
Ospedale San Francesco
🇮🇹Nuoro, Italy
Centre Cardio Thoracique
🇲🇨Monaco, Monaco
Jeroen Bosch Hospital
🇳🇱Den Bosch, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Erasmus University
🇳🇱Rotterdam, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands
Hospital de Navarra
🇪🇸Pamplona, Spain
Hospital Universitari Parc Tauli
🇪🇸Sabadell, Spain
Kantonsspital Graubunden
🇨ðŸ‡Chur, Switzerland
University Hospital Bern
🇨ðŸ‡Bern, Switzerland
Uppsala University
🇸🇪Uppsala, Sweden
Royal Derby Hospital
🇬🇧Derby, United Kingdom
Hospital Donostia
🇪🇸San Sebastian, Spain
Frimley Park Hospital
🇬🇧Frimley, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
The Royal London Hospital
🇬🇧London, United Kingdom
Imperial (St Mary's / Charing X) Hospital
🇬🇧London, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Western Infirmary/Gartnavel
🇬🇧Glasgow, United Kingdom
The Royal Free Hospital
🇬🇧London, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Royal Preston Hospital
🇬🇧Preston, United Kingdom
Hospital Universitario La Paz
🇪🇸Madrid, Spain