Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft | 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. | For 5 years post-implant |
Not provided
Not provided
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:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Franz Josef Spital | Vienna | Austria | ||||
| Krankenhaus Hietzing |
Not provided
Not provided
Not provided
Not provided
| 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 | DE22 3NE | 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 |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided