The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Bonheiden, Belgien
- Imelda Hospital
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Brussels, Belgien
- St Luc Brussels
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Brussels, Belgien
- University Hospital, Brussels
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Charleroi, Belgien
- Grand Hôpital de Charleroi
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Roeselare, Belgien
- H.-Hartziekenhuis Roeselare-Menen
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Bordeaux, Frankrike
- Hôpital Pellegrin
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Creteil, Frankrike
- CHU Henri Mondor
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Draguignan, Frankrike
- Chirurgien Vasculaire
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Nancy, Frankrike
- Clinique Ambrose Paré
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Paris, Frankrike
- La Pitié
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Paris, Frankrike
- Le Plessis Robinson
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Tours, Frankrike
- CHU Tours
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Bologna, Italien
- University of Bologna
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Nuoro, Italien
- Ospedale San Francesco
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Palermo, Italien
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel
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Rome, Italien
- San Filippo Neri Hospital
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Calgary, Kanada
- Peter Lougheed Centre
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Halifax, Kanada
- QE2 Hospital
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London, Ontario, Kanada
- London Health Sciences Centre
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Montreal, Kanada
- Royal Victoria Hospital
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Ottawa, Kanada
- The Ottawa Hospital
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St Johns, Kanada
- St Clare's Mercy Hospital
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Toronto, Kanada
- Toronto General Hospital
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Winnipeg, Kanada
- Health Science Centre
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Monaco, Monaco
- Centre Cardio Thoracique
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Den Bosch, Nederländerna
- Jeroen Bosch Hospital
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Enschede, Nederländerna
- Medisch Spectrum Twente
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Maastricht, Nederländerna
- Maastricht University Medical Centre
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Rotterdam, Nederländerna
- Erasmus University
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Zwolle, Nederländerna
- Isala Klinieken
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Bern, Schweiz
- University Hospital Bern
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Chur, Schweiz
- Kantonsspital Graubunden
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Madrid, Spanien
- Hospital Universitario La Paz
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Pamplona, Spanien
- Hospital de Navarra
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Sabadell, Spanien
- Hospital Universitari Parc Tauli
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San Sebastian, Spanien
- Hospital Donostia
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Derby, Storbritannien, DE22 3NE
- Royal Derby Hospital
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Frimley, Storbritannien
- Frimley Park Hospital
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Glasgow, Storbritannien
- Western Infirmary/Gartnavel
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Leeds, Storbritannien
- Leeds General Infirmary
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Leicester, Storbritannien
- Leicester Royal Infirmary
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London, Storbritannien
- Kings College Hospital
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London, Storbritannien
- The Royal London Hospital
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London, Storbritannien
- The Royal Free Hospital
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London, Storbritannien
- Imperial (St Mary's / Charing X) Hospital
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Newcastle, Storbritannien
- Freeman Hospital
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Oxford, Storbritannien
- John Radcliffe Hospital
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Preston, Storbritannien
- Royal Preston Hospital
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Uppsala, Sverige
- Uppsala University
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Aachen, Tyskland
- University Hospital Aachen
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Aachen, Tyskland
- Luisenhospital - Aachen
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Augsburg, Tyskland
- Klinikum Augsburg
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Bremen, Tyskland
- Red Cross hospital clinic
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Cologne, Tyskland
- University of Cologne
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Frankfurt, Tyskland
- Klinikum Frankfurt Höchst
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Freiburg, Tyskland
- Universitatsklinikum Freiburg
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Freital, Tyskland
- Krankenhaus Freital
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Goettingen, Tyskland
- Chirurgie am Waldweg
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Groningen, Tyskland
- University of Groningen
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Hamburg, Tyskland
- Asklepios Klinik Altona
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Hamm, Tyskland
- Medical Care Centre for Vascular Diseases
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Kevelaer, Tyskland
- Marienhospital
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Lingen, Tyskland
- Bonifacius Hospital
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Munich, Tyskland
- University Hospital
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Neustrelitz, Tyskland
- DRK Krankenhaus Neustrelitz
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Regensburg, Tyskland
- Krankenhaus Barmherzige Brüder
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Regensburg, Tyskland
- University Hospital
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Solingen, Tyskland
- Klinikum Solingen
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Witten, Tyskland
- Marien-Hospital Witten
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Vienna, Österrike
- Krankenhaus Hietzing
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Vienna, Österrike
- Kaiser Franz Josef Spital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft
Tidsram: For 5 years post-implant
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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.
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For 5 years post-implant
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CFD001
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