Abdominal Aortic Aneurysms (AAA)NCT01826344
The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
An observational study of Abdominal Aortic Aneurysms (AAA), run by Vascutek Ltd. at 71 sites in 12 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms (AAA)
- How many people
- 628 participants
- Where
- 71 sitesin 12 countries
- Study dates
- Jun 2010to Dec 2015
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
71 sites in 12 countries.
71 sites in 12 countries
Germany20 sites
Luisenhospital - Aachen
Aachen
University Hospital Aachen
Aachen
Klinikum Augsburg
Augsburg
Red Cross hospital clinic
Bremen
University of Cologne
Cologne
Klinikum Frankfurt Hochst
Frankfurt
Universitatsklinikum Freiburg
Freiburg im Breisgau
Krankenhaus Freital
Freital
Chirurgie am Waldweg
Göttingen
University of Groningen
Gröningen
Asklepios Klinik Altona
Hamburg
Medical Care Centre for Vascular Diseases
Hamm
Marienhospital
Kevelaer
Bonifacius Hospital
Lingen
University Hospital
Munich
DRK Krankenhaus Neustrelitz
Neustrelitz
Krankenhaus Barmherzige Bruder
Regensburg
University Hospital
Regensburg
Klinikum Solingen
Solingen
Marien-Hospital Witten
Witten
United Kingdom12 sites
Royal Derby Hospital
Derby, DE22 3NE
Frimley Park Hospital
Frimley
Western Infirmary/Gartnavel
Glasgow
Leeds General Infirmary
Leeds
Leicester Royal Infirmary
Leicester
Imperial (St Mary's / Charing X) Hospital
London
Kings College Hospital
London
The Royal Free Hospital
London
The Royal London Hospital
London
Freeman Hospital
Newcastle
John Radcliffe Hospital
Oxford
Royal Preston Hospital
Preston
Canada8 sites
Peter Lougheed Centre
Calgary
QE2 Hospital
Halifax
London Health Sciences Centre
London, Ontario
Royal Victoria Hospital
Montreal
The Ottawa Hospital
Ottawa
St Clare's Mercy Hospital
St. Johns
Toronto General Hospital
Toronto
Health Science Centre
Winnipeg
France7 sites
Hopital Pellegrin
Bordeaux
CHU Henri Mondor
Créteil
Chirurgien Vasculaire
Draguignan
Clinique Ambrose Paré
Nancy
La Pitie
Paris
Le Plessis Robinson
Paris
CHU Tours
Tours
Belgium5 sites
Imelda Hospital
Bonheiden
St Luc Brussels
Brussels
University Hospital, Brussels
Brussels
Grand Hôpital de Charleroi
Charleroi
H.-Hartziekenhuis Roeselare-Menen
Roeselare
Netherlands5 sites
Jeroen Bosch Hospital
's-Hertogenbosch
Medisch Spectrum Twente
Enschede
Maastricht University Medical Centre
Maastricht
Erasmus University
Rotterdam
Isala Klinieken
Zwolle
Italy4 sites
University of Bologna
Bologna
Ospedale San Francesco
Nuoro
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel
Palermo
San Filippo Neri Hospital
Rome
Spain4 sites
Hospital Donostia
Donostia / San Sebastian
Hospital Universitario La Paz
Madrid
Hospital de Navarra
Pamplona
Hospital Universitari Parc Tauli
Sabadell
Switzerland2 sites
University Hospital Bern
Bern
Kantonsspital Graubunden
Chur
About this study
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysms (AAA)
- Medical subject headings
- Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For 5 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJun 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysms (AAA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 628 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826344
- Sponsor's protocol ID
- CFD001
- Status last verified
- Dec 2015
- First submitted
- 3 Apr 2013
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
- ClinicalTrials.gov ID
- NCT01826344
- Acronym / sponsor ID
- CFD001
- Conditions
- Abdominal Aortic Aneurysms (AAA)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
71 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysms (AAA), run by Vascutek Ltd. at 71 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in Germany, United Kingdom, Canada, France, Belgium and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.