The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study

December 8, 2015 updated by: Vascutek Ltd.
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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

628

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Krankenhaus Hietzing
      • Vienna, Austria
        • Kaiser Franz Josef Spital
  • Belgium
      • Bonheiden, Belgium
        • Imelda Hospital
      • Brussels, Belgium
        • St Luc Brussels
      • Brussels, Belgium
        • University Hospital, Brussels
      • Charleroi, Belgium
        • Grand Hôpital de Charleroi
      • Roeselare, Belgium
        • H.-Hartziekenhuis Roeselare-Menen
  • Canada
      • Calgary, Canada
        • Peter Lougheed Centre
      • Halifax, Canada
        • QE2 Hospital
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Montreal, Canada
        • Royal Victoria Hospital
      • Ottawa, Canada
        • The Ottawa Hospital
      • St Johns, Canada
        • St Clare's Mercy Hospital
      • Toronto, Canada
        • Toronto General Hospital
      • Winnipeg, Canada
        • Health Science Centre
  • France
      • Bordeaux, France
        • Hôpital Pellegrin
      • Creteil, France
        • CHU Henri Mondor
      • Draguignan, France
        • Chirurgien Vasculaire
      • Nancy, France
        • Clinique Ambrose Paré
      • Paris, France
        • La Pitié
      • Paris, France
        • Le Plessis Robinson
      • Tours, France
        • CHU Tours
  • Germany
      • Aachen, Germany
        • University Hospital Aachen
      • Aachen, Germany
        • Luisenhospital - Aachen
      • Augsburg, Germany
        • Klinikum Augsburg
      • Bremen, Germany
        • Red Cross hospital clinic
      • Cologne, Germany
        • University of Cologne
      • Frankfurt, Germany
        • Klinikum Frankfurt Höchst
      • Freiburg, Germany
        • Universitätsklinikum Freiburg
      • Freital, Germany
        • Krankenhaus Freital
      • Goettingen, Germany
        • Chirurgie am Waldweg
      • Groningen, Germany
        • University of Groningen
      • Hamburg, Germany
        • Asklepios Klinik Altona
      • Hamm, Germany
        • Medical Care Centre for Vascular Diseases
      • Kevelaer, Germany
        • Marienhospital
      • Lingen, Germany
        • Bonifacius Hospital
      • Munich, Germany
        • University Hospital
      • Neustrelitz, Germany
        • DRK Krankenhaus Neustrelitz
      • Regensburg, Germany
        • Krankenhaus Barmherzige Brüder
      • Regensburg, Germany
        • University Hospital
      • Solingen, Germany
        • Klinikum Solingen
      • Witten, Germany
        • Marien-Hospital Witten
  • Italy
      • Bologna, Italy
        • University of Bologna
      • Nuoro, Italy
        • Ospedale San Francesco
      • Palermo, Italy
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel
      • Rome, Italy
        • San Filippo Neri Hospital
  • Monaco
      • Monaco, Monaco
        • Centre Cardio Thoracique
  • Netherlands
      • Den Bosch, Netherlands
        • Jeroen Bosch Hospital
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Maastricht, Netherlands
        • Maastricht University Medical Centre
      • Rotterdam, Netherlands
        • Erasmus University
      • Zwolle, Netherlands
        • Isala Klinieken
  • Spain
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Pamplona, Spain
        • Hospital de Navarra
      • Sabadell, Spain
        • Hospital Universitari Parc Tauli
      • San Sebastian, Spain
        • Hospital Donostia
  • Sweden
      • Uppsala, Sweden
        • Uppsala University
  • Switzerland
      • Bern, Switzerland
        • University Hospital Bern
      • Chur, Switzerland
        • Kantonsspital Graubunden
  • United Kingdom
      • Derby, United Kingdom, DE22 3NE
        • Royal Derby Hospital
      • Frimley, United Kingdom
        • Frimley Park Hospital
      • Glasgow, United Kingdom
        • Western Infirmary/Gartnavel
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • Leicester, United Kingdom
        • Leicester Royal Infirmary
      • London, United Kingdom
        • Kings College Hospital
      • London, United Kingdom
        • The Royal London Hospital
      • London, United Kingdom
        • The Royal Free Hospital
      • London, United Kingdom
        • Imperial (St Mary's / Charing X) Hospital
      • Newcastle, United Kingdom
        • Freeman Hospital
      • Oxford, United Kingdom
        • John Radcliffe Hospital
      • Preston, United Kingdom
        • Royal Preston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascutek Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFD001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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