The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
1 other identifier
observational
628
12 countries
71
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Longer than P75 for all trials
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 3, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 9, 2015
December 1, 2015
5.5 years
April 3, 2013
December 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vascutek Ltd.lead
Study Sites (71)
Kaiser Franz Josef Spital
Vienna, Austria
Krankenhaus Hietzing
Vienna, Austria
Imelda Hospital
Bonheiden, Belgium
St Luc Brussels
Brussels, Belgium
University Hospital, Brussels
Brussels, Belgium
Grand HĂ´pital 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2013
First Posted
April 8, 2013
Study Start
June 1, 2010
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 9, 2015
Record last verified: 2015-12