The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
NCT ID: NCT01826344
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
628 participants
OBSERVATIONAL
2010-06-30
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Vascutek Ltd.
INDUSTRY
Responsible Party
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Locations
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Kaiser Franz Josef Spital
Vienna, , Austria
Krankenhaus Hietzing
Vienna, , Austria
Imelda Hospital
Bonheiden, , Belgium
St Luc Brussels
Brussels, , Belgium
University Hospital, Brussels
Brussels, , Belgium
Grand Hôpital de Charleroi
Charleroi, , Belgium
H.-Hartziekenhuis Roeselare-Menen
Roeselare, , Belgium
Peter Lougheed Centre
Calgary, , Canada
QE2 Hospital
Halifax, , Canada
London Health Sciences Centre
London, Ontario, , Canada
Royal Victoria Hospital
Montreal, , Canada
The Ottawa Hospital
Ottawa, , Canada
St Clare's Mercy Hospital
St. Johns, , Canada
Toronto General Hospital
Toronto, , Canada
Health Science Centre
Winnipeg, , Canada
Hopital Pellegrin
Bordeaux, , France
CHU Henri Mondor
Créteil, , France
Chirurgien Vasculaire
Draguignan, , France
Clinique Ambrose Paré
Nancy, , France
La Pitie
Paris, , France
Le Plessis Robinson
Paris, , France
CHU Tours
Tours, , 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
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
Krankenhaus Freital
Freital, , Germany
Chirurgie am Waldweg
Göttingen, , Germany
University of Groningen
Gröningen, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
Medical Care Centre for Vascular Diseases
Hamm, , Germany
Marienhospital
Kevelaer, , Germany
Bonifacius Hospital
Lingen, , Germany
University Hospital
Munich, , Germany
DRK Krankenhaus Neustrelitz
Neustrelitz, , Germany
Krankenhaus Barmherzige Bruder
Regensburg, , Germany
University Hospital
Regensburg, , Germany
Klinikum Solingen
Solingen, , Germany
Marien-Hospital Witten
Witten, , Germany
University of Bologna
Bologna, , Italy
Ospedale San Francesco
Nuoro, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel
Palermo, , Italy
San Filippo Neri Hospital
Rome, , Italy
Centre Cardio Thoracique
Monaco, , Monaco
Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Maastricht University Medical Centre
Maastricht, , Netherlands
Erasmus University
Rotterdam, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Hospital Donostia
Donostia / San Sebastian, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital de Navarra
Pamplona, , Spain
Hospital Universitari Parc Tauli
Sabadell, , Spain
Uppsala University
Uppsala, , Sweden
University Hospital Bern
Bern, , Switzerland
Kantonsspital Graubunden
Chur, , Switzerland
Royal Derby Hospital
Derby, , United Kingdom
Frimley Park Hospital
Frimley, , United Kingdom
Western Infirmary/Gartnavel
Glasgow, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Imperial (St Mary's / Charing X) Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
The Royal Free Hospital
London, , United Kingdom
The Royal London Hospital
London, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Countries
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Other Identifiers
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CFD001
Identifier Type: -
Identifier Source: org_study_id