The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Vascutek Ltd.
Sponsor:
Information provided by (Responsible Party):
Vascutek Ltd.
ClinicalTrials.gov Identifier:
NCT01826344
First received: April 3, 2013
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition
Abdominal Aortic Aneurysms (AAA)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years

Resource links provided by NLM:


Further study details as provided by Vascutek Ltd.:

Primary Outcome Measures:
  • To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft [ Time Frame: For 5 years post-implant ] [ Designated as safety issue: No ]
    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.


Study Start Date: June 2010
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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:

  1. Ruptured or symptomatic aneurysm
  2. Clinically significant concomitant medical disease or infection
  3. Connective Tissue Disease (e.g. Marfan's Syndrome)
  4. Known allergy to nitinol, polyester or contrast medium
  5. Excessive tortuosity of access vessels (femoral or iliac arteries)
  6. Landing zone of less than 10mm in the visceral segment of the aorta
  7. Inability to comply to follow up protocol
  8. Access vessels less than 6mm in diameter
  9. Diseased or excessively tortuous access to target vessels
  10. Target vessels of less than 5mm in calibre
  11. Excessive calcification or thrombus at the intended landing zone which could affect sealing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826344

Contacts
Contact: Dr Peter Bungay peter.bungay@derbyhospitals.nhs.uk

  Hide Study Locations
Locations
Austria
Krankenhaus Hietzing Recruiting
Vienna, Austria
Contact: Dr G Mertikian         
Kaiser Franz Josef Spital Recruiting
Vienna, Austria
Contact: Dr Berg         
Belgium
Imelda Hospital Recruiting
Bonheiden, Belgium
Contact: Dr Peeters         
University Hospital, Brussels Recruiting
Brussels, Belgium
Contact: Prof Debing         
St Luc Brussels Recruiting
Brussels, Belgium
Contact: Dr Verhelst         
Grand Hôpital de Charleroi Recruiting
Charleroi, Belgium
Contact: Dr Remy         
H.-Hartziekenhuis Roeselare-Menen Recruiting
Roeselare, Belgium
Contact: Dr Danneels         
Canada
Peter Lougheed Centre Recruiting
Calgary, Canada
Contact: Dr R Moore         
QE2 Hospital Recruiting
Halifax, Canada
Contact: Dr Casey         
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Dr G Derose         
Royal Victoria Hospital Recruiting
Montreal, Canada
Contact: Dr Mackenzie         
The Ottawa Hospital Recruiting
Ottawa, Canada
Contact: Dr S Nagpal         
St Clare's Mercy Hospital Recruiting
St Johns, Canada
Contact: Dr Melvin         
Toronto General Hospital Recruiting
Toronto, Canada
Contact: Dr L Tse         
Health Science Centre Recruiting
Winnipeg, Canada
Contact: Dr Hardy         
France
Hopital Pellegrin Recruiting
Bordeaux, France
Contact: Prof D Midy         
CHU Henri Mondor Recruiting
Creteil, France
Contact: Prof J P Becquemin         
Chirurgien Vasculaire Recruiting
Draguignan, France
Contact: Dr J Albertin         
Clinique Ambrose Paré Recruiting
Nancy, France
Contact: Prof Bour         
La Pitie Recruiting
Paris, France
Contact: Professor Koskas         
Le Plessis Robinson Recruiting
Paris, France
Contact: Dr Fabre         
CHU Tours Recruiting
Tours, France
Contact: Dr R Martinez         
Germany
Luisenhospital - Aachen Recruiting
Aachen, Germany
Contact: Dr U Radtke         
University Hospital Aachen Recruiting
Aachen, Germany
Contact: Dr J Kalder         
Klinikum Augsburg Recruiting
Augsburg, Germany
Contact: Dr Jakob         
Red Cross hospital clinic Recruiting
Bremen, Germany
Contact: Dr F Marquardt         
University of Cologne Recruiting
Cologne, Germany
Contact: Prof M Gawenda         
Klinikum Frankfurt Hochst Recruiting
Frankfurt, Germany
Contact: Dr G Rouhani         
Universitatsklinikum Freiburg Recruiting
Freiburg, Germany
Contact: Dr Euringer         
Krankenhaus Freital Recruiting
Freital, Germany
Contact: Dr H Florek         
Chirurgie am Waldweg Recruiting
Goettingen, Germany
Contact: Dr Kranz         
University of Groningen Recruiting
Groningen, Germany
Contact: Dr I F J Tielliu         
Asklepios Klinik Altona Recruiting
Hamburg, Germany
Contact: Prof H Kortmann         
Medical Care Centre for Vascular Diseases Recruiting
Hamm, Germany
Contact: Dr W F Gabel         
Marienhospital Recruiting
Kevelaer, Germany
Contact: Dr P Berg         
Bonifacius Hospital Recruiting
Lingen, Germany
Contact: Dr J Tesarek         
University Hospital Recruiting
Munich, Germany
Contact: Dr R Weidenhagen         
DRK Krankenhaus Neustrelitz Recruiting
Neustrelitz, Germany
Contact: Dr R Kastrau         
Krankenhaus Barmherzige Bruder Recruiting
Regensburg, Germany
Contact: Prof M Steinbauer         
University Hospital Recruiting
Regensburg, Germany
Contact: Dr Kasprzak         
Klinikum Solingen Recruiting
Solingen, Germany
Contact: Dr Hoffmann         
Marien-Hospital Witten Recruiting
Witten, Germany
Contact: Dr S Langer         
Italy
University of Bologna Recruiting
Bologna, Italy
Contact: Prof Stella         
Ospedale San Francesco Recruiting
Nuoro, Italy
Contact: Dr Fadda         
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel Recruiting
Palermo, Italy
Contact: Prof Talarico         
San Filippo Neri Hospital Recruiting
Rome, Italy
Contact: Prof Mangialardi         
Monaco
Centre Cardio Thoracique Recruiting
Monaco, Monaco
Contact: Dr C Mialhe         
Netherlands
Jeroen Bosch Hospital Recruiting
Den Bosch, Netherlands
Contact: Dr O Koning         
Medisch Spectrum Twente Recruiting
Enschede, Netherlands
Contact: Dr R Meerwaldt         
Maastricht University Medical Centre Recruiting
Maastricht, Netherlands
Contact: Dr G W H Schurink         
Erasmus University Recruiting
Rotterdam, Netherlands
Contact: Dr Brussel         
Isala Klinieken Recruiting
Zwolle, Netherlands
Contact: Dr M Pierie         
Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: Dr Garzon         
Hospital de Navarra Recruiting
Pamplona, Spain
Contact: Dr Roberto Centeno         
Hospital Universitari Parc Tauli Recruiting
Sabadell, Spain
Contact: Dr Gaibar         
Hospital Donostia Recruiting
San Sebastian, Spain
Contact: Dr De Blas         
Sweden
Uppsala University Recruiting
Uppsala, Sweden
Contact: Prof R Nyman         
Switzerland
University Hospital Bern Recruiting
Bern, Switzerland
Contact: Prof J Schmidli         
Kantonsspital Graubunden Recruiting
Chur, Switzerland
Contact: Prof M Furrer         
United Kingdom
Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Contact: Dr Peter Bungay         
Frimley Park Hospital Recruiting
Frimley, United Kingdom
Contact: Mr D J Gerrard         
Western Infirmary/Gartnavel Recruiting
Glasgow, United Kingdom
Contact: Dr R Kasthuri         
Leeds General Infirmary Recruiting
Leeds, United Kingdom
Contact: Dr S Puppala         
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom
Contact: Dr M Glasby         
Kings College Hospital Recruiting
London, United Kingdom
Contact: Dr J Wilkins         
The Royal Free Hospital Recruiting
London, United Kingdom
Contact: Dr N Davies         
The Royal London Hospital Recruiting
London, United Kingdom
Contact: Dr Matson         
Imperial (St Mary's / Charing X) Hospital Recruiting
London, United Kingdom
Contact: Dr N Burfitt         
Freeman Hospital Recruiting
Newcastle, United Kingdom
Contact: Dr R Williams         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom
Contact: Dr M Bratby         
Royal Preston Hospital Recruiting
Preston, United Kingdom
Contact: Dr Seriki         
Sponsors and Collaborators
Vascutek Ltd.
  More Information

No publications provided

Responsible Party: Vascutek Ltd.
ClinicalTrials.gov Identifier: NCT01826344     History of Changes
Other Study ID Numbers: CFD001
Study First Received: April 3, 2013
Last Updated: July 8, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 24, 2014