The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Bonheiden, Belgia
- Imelda Hospital
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Brussels, Belgia
- St Luc Brussels
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Brussels, Belgia
- University Hospital, Brussels
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Charleroi, Belgia
- Grand Hôpital de Charleroi
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Roeselare, Belgia
- 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, 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, 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, Nederland
- Jeroen Bosch Hospital
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Enschede, Nederland
- Medisch Spectrum Twente
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Maastricht, Nederland
- Maastricht University Medical Centre
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Rotterdam, Nederland
- Erasmus University
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Zwolle, Nederland
- Isala Klinieken
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Madrid, Spania
- Hospital Universitario La Paz
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Pamplona, Spania
- Hospital de Navarra
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Sabadell, Spania
- Hospital Universitari Parc Tauli
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San Sebastian, Spania
- Hospital Donostia
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Derby, Storbritannia, DE22 3NE
- Royal Derby Hospital
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Frimley, Storbritannia
- Frimley Park Hospital
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Glasgow, Storbritannia
- Western Infirmary/Gartnavel
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Leeds, Storbritannia
- Leeds General Infirmary
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Leicester, Storbritannia
- Leicester Royal Infirmary
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London, Storbritannia
- Kings College Hospital
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London, Storbritannia
- The Royal London Hospital
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London, Storbritannia
- The Royal Free Hospital
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London, Storbritannia
- Imperial (St Mary's / Charing X) Hospital
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Newcastle, Storbritannia
- Freeman Hospital
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Oxford, Storbritannia
- John Radcliffe Hospital
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Preston, Storbritannia
- Royal Preston Hospital
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Bern, Sveits
- University Hospital Bern
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Chur, Sveits
- Kantonsspital Graubunden
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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, Østerrike
- Krankenhaus Hietzing
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Vienna, Østerrike
- Kaiser Franz Josef Spital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CFD001
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