The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vascutek Ltd.
ClinicalTrials.gov Identifier:
NCT01826344
First received: April 3, 2013
Last updated: March 2, 2015
Last verified: March 2015
  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.


Estimated Enrollment: 750
Study Start Date: June 2010
Estimated Study Completion Date: June 2020
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

  Hide Study Locations
Locations
Austria
Kaiser Franz Josef Spital
Vienna, Austria
Krankenhaus Hietzing
Vienna, Austria
Belgium
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
Canada
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
France
Hopital Pellegrin
Bordeaux, France
CHU Henri Mondor
Creteil, France
Chirurgien Vasculaire
Draguignan, France
Clinique Ambrose Paré
Nancy, France
Le Plessis Robinson
Paris, France
La Pitie
Paris, France
CHU Tours
Tours, France
Germany
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, Germany
Krankenhaus Freital
Freital, Germany
Chirurgie am Waldweg
Goettingen, Germany
University of Groningen
Groningen, 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
Italy
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
Monaco
Centre Cardio Thoracique
Monaco, Monaco
Netherlands
Jeroen Bosch Hospital
Den Bosch, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Erasmus University
Rotterdam, Netherlands
Isala Klinieken
Zwolle, Netherlands
Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital de Navarra
Pamplona, Spain
Hospital Universitari Parc Tauli
Sabadell, Spain
Hospital Donostia
San Sebastian, Spain
Sweden
Uppsala University
Uppsala, Sweden
Switzerland
University Hospital Bern
Bern, Switzerland
Kantonsspital Graubunden
Chur, Switzerland
United Kingdom
Royal Derby Hospital
Derby, United Kingdom, DE22 3NE
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
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: March 2, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on March 31, 2015