The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Calgary、加拿大
- Peter Lougheed Centre
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Halifax、加拿大
- QE2 Hospital
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London, Ontario、加拿大
- London Health Sciences Centre
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Montreal、加拿大
- Royal Victoria Hospital
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Ottawa、加拿大
- The Ottawa Hospital
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St Johns、加拿大
- St Clare's Mercy Hospital
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Toronto、加拿大
- Toronto General Hospital
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Winnipeg、加拿大
- Health Science Centre
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Vienna、奥地利
- Krankenhaus Hietzing
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Vienna、奥地利
- Kaiser Franz Josef Spital
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Aachen、德国
- University Hospital Aachen
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Aachen、德国
- Luisenhospital - Aachen
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Augsburg、德国
- Klinikum Augsburg
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Bremen、德国
- Red Cross hospital clinic
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Cologne、德国
- University of Cologne
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Frankfurt、德国
- Klinikum Frankfurt Höchst
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Freiburg、德国
- Universitatsklinikum Freiburg
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Freital、德国
- Krankenhaus Freital
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Goettingen、德国
- Chirurgie am Waldweg
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Groningen、德国
- University of Groningen
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Hamburg、德国
- Asklepios Klinik Altona
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Hamm、德国
- Medical Care Centre for Vascular Diseases
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Kevelaer、德国
- Marienhospital
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Lingen、德国
- Bonifacius Hospital
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Munich、德国
- University Hospital
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Neustrelitz、德国
- DRK Krankenhaus Neustrelitz
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Regensburg、德国
- Krankenhaus Barmherzige Brüder
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Regensburg、德国
- University Hospital
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Solingen、德国
- Klinikum Solingen
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Witten、德国
- Marien-Hospital Witten
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Bologna、意大利
- University of Bologna
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Nuoro、意大利
- Ospedale San Francesco
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Palermo、意大利
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel
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Rome、意大利
- San Filippo Neri Hospital
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Monaco、摩纳哥
- Centre Cardio Thoracique
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Bonheiden、比利时
- Imelda Hospital
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Brussels、比利时
- St Luc Brussels
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Brussels、比利时
- University Hospital, Brussels
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Charleroi、比利时
- Grand Hôpital de Charleroi
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Roeselare、比利时
- H.-Hartziekenhuis Roeselare-Menen
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Bordeaux、法国
- Hôpital Pellegrin
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Creteil、法国
- CHU Henri Mondor
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Draguignan、法国
- Chirurgien Vasculaire
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Nancy、法国
- Clinique Ambrose Paré
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Paris、法国
- La Pitié
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Paris、法国
- Le Plessis Robinson
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Tours、法国
- CHU Tours
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Uppsala、瑞典
- Uppsala University
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Bern、瑞士
- University Hospital Bern
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Chur、瑞士
- Kantonsspital Graubunden
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Derby、英国、DE22 3NE
- Royal Derby Hospital
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Frimley、英国
- Frimley Park Hospital
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Glasgow、英国
- Western Infirmary/Gartnavel
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Leeds、英国
- Leeds General Infirmary
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Leicester、英国
- Leicester Royal Infirmary
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London、英国
- Kings College Hospital
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London、英国
- The Royal London Hospital
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London、英国
- The Royal Free Hospital
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London、英国
- Imperial (St Mary's / Charing X) Hospital
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Newcastle、英国
- Freeman Hospital
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Oxford、英国
- John Radcliffe Hospital
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Preston、英国
- Royal Preston Hospital
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Den Bosch、荷兰
- Jeroen Bosch Hospital
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Enschede、荷兰
- Medisch Spectrum Twente
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Maastricht、荷兰
- Maastricht University Medical Centre
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Rotterdam、荷兰
- Erasmus University
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Zwolle、荷兰
- Isala Klinieken
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Madrid、西班牙
- Hospital Universitario La Paz
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Pamplona、西班牙
- Hospital de Navarra
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Sabadell、西班牙
- Hospital Universitari Parc Tauli
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San Sebastian、西班牙
- Hospital Donostia
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft
大体时间：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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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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