The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Vienna, Austria
- Krankenhaus Hietzing
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Vienna, Austria
- Kaiser Franz Josef Spital
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Bonheiden, Belgio
- Imelda Hospital
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Brussels, Belgio
- St Luc Brussels
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Brussels, Belgio
- University Hospital, Brussels
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Charleroi, Belgio
- Grand Hopital de Charleroi
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Roeselare, Belgio
- H.-Hartziekenhuis Roeselare-Menen
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Calgary, Canada
- Peter Lougheed Centre
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Halifax, Canada
- QE2 Hospital
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London, Ontario, Canada
- London Health Sciences Centre
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Montreal, Canada
- Royal Victoria Hospital
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Ottawa, Canada
- The Ottawa Hospital
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St Johns, Canada
- St Clare's Mercy Hospital
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Toronto, Canada
- Toronto General Hospital
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Winnipeg, Canada
- Health Science Centre
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Bordeaux, Francia
- Hôpital Pellegrin
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Creteil, Francia
- CHU Henri Mondor
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Draguignan, Francia
- Chirurgien Vasculaire
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Nancy, Francia
- Clinique Ambrose Paré
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Paris, Francia
- La Pitié
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Paris, Francia
- Le Plessis Robinson
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Tours, Francia
- CHU Tours
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Aachen, Germania
- University Hospital Aachen
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Aachen, Germania
- Luisenhospital - Aachen
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Augsburg, Germania
- Klinikum Augsburg
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Bremen, Germania
- Red Cross hospital clinic
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Cologne, Germania
- University of Cologne
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Frankfurt, Germania
- Klinikum Frankfurt Höchst
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Freiburg, Germania
- Universitätsklinikum Freiburg
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Freital, Germania
- Krankenhaus Freital
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Goettingen, Germania
- Chirurgie am Waldweg
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Groningen, Germania
- University of Groningen
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Hamburg, Germania
- Asklepios Klinik Altona
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Hamm, Germania
- Medical Care Centre for Vascular Diseases
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Kevelaer, Germania
- Marienhospital
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Lingen, Germania
- Bonifacius Hospital
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Munich, Germania
- University Hospital
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Neustrelitz, Germania
- DRK Krankenhaus Neustrelitz
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Regensburg, Germania
- Krankenhaus Barmherzige Brüder
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Regensburg, Germania
- University Hospital
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Solingen, Germania
- Klinikum Solingen
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Witten, Germania
- Marien-Hospital Witten
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Bologna, Italia
- University of Bologna
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Nuoro, Italia
- Ospedale San Francesco
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Palermo, Italia
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel
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Rome, Italia
- San Filippo Neri Hospital
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Monaco, Monaco
- Centre Cardio Thoracique
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Den Bosch, Olanda
- Jeroen Bosch Hospital
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Enschede, Olanda
- Medisch Spectrum Twente
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Maastricht, Olanda
- Maastricht University Medical Centre
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Rotterdam, Olanda
- Erasmus University
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Zwolle, Olanda
- Isala Klinieken
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Derby, Regno Unito, DE22 3NE
- Royal Derby Hospital
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Frimley, Regno Unito
- Frimley Park Hospital
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Glasgow, Regno Unito
- Western Infirmary/Gartnavel
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Leeds, Regno Unito
- Leeds General Infirmary
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Leicester, Regno Unito
- Leicester Royal Infirmary
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London, Regno Unito
- Kings College Hospital
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London, Regno Unito
- The Royal London Hospital
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London, Regno Unito
- The Royal Free Hospital
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London, Regno Unito
- Imperial (St Mary's / Charing X) Hospital
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Newcastle, Regno Unito
- Freeman Hospital
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Oxford, Regno Unito
- John Radcliffe Hospital
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Preston, Regno Unito
- Royal Preston Hospital
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Madrid, Spagna
- Hospital Universitario La Paz
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Pamplona, Spagna
- Hospital De Navarra
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Sabadell, Spagna
- Hospital Universitari Parc Taulí
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San Sebastian, Spagna
- Hospital Donostia
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Uppsala, Svezia
- Uppsala University
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Bern, Svizzera
- University Hospital Bern
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Chur, Svizzera
- Kantonsspital Graubünden
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CFD001
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