Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
160 participants
OBSERVATIONAL
2017-09-11
2030-12-31
Brief Summary
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Detailed Description
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The Fenestrated Anaconda™ device (Vascutek Ltd, Glasgow, Scotland, UK) has been commercially available since 2010. The Fenestrated Anaconda™ device has potential advantages over other FEVAR devices, since it can be repositioned after deployment, has a magnet-assisted limb cannulation, and the device contains less metal, allowing a better view of the radiological markers on the device during intra-operative imaging. Additionally, the potential to position fenestrations anywhere in the main body is unrestricted due to the absence of other stent structures.
This prospective, real world study of the Fenestrated Anaconda™ device will provide insight into both the short and long term clinical outcomes of the device. An attempt will be made to identify predictors of success or failure, and this study will help to identify patients that are likely to benefit from repair and improve results. The effect of FEVAR on post-operative patient reported quality of life will be assessed. In addition, the study will provide insight into the potential decline in renal function after FEVAR, a well-known concern after both EVAR and FEVAR.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System
Fenestrated Endovascular Aortic Repair (FEVAR)
Eligibility Criteria
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Inclusion Criteria
1. Patient is aged 18 years or over on the date of consent
2. Patient is willing and able to comply with all study procedures and study follow-up visits
3. Patient is willing and able to give written informed consent to participate in study
4. Patient has a juxtrarenal or suprarenal abdominal aortic aneurysm (AAA) with maximum sac diameter ≥ 5.5cm, or an AAA ≥ 4.5 cm which has increased by \> 1.0 cm in the past year
5. Patient is anatomically suitable for a bifurcated Fenestrated Anaconda™ device
NOTE: Both the treating Investigator and the Manufacturer must agree that the proposed patient's anatomy is suitable for treatment using the Fenestrated Anaconda™ device. Where the Investigator proposes that the patient anatomy is suitable and the Manufacturer subsequently disagrees, the patient will be recorded as a screen failure and deemed not eligible for the study.
Exclusion Criteria
1. Patient has a life expectancy \< 2 years, as judged by the Investigator
2. Patient has psychiatric or other condition that in the opinion of the Investigator may limit their ability to comply with study procedures
3. Patient is participating in another clinical study which in the opinion of the Investigator could influence the outcomes of this study
4. Patient has a known allergy to any device component (polyester, nitinol, nickel)
5. Patient has a coagulopathy or uncontrolled bleeding disorder
6. Patient has a ruptured, leaking or mycotic aneurysm
7. Patient has a serum creatinine (S-Cr) level \> 2.0 mg/dL (177 µmol/L)
8. Patient has had CVA or MI within three months of enrolment or treatment
9. Patient has a connective tissue disease (e.g. Marfan Syndrome)
10. Patient has had a previously inserted endovascular stent in the abdominal aorta
11. Patient is pregnant (female of childbearing potential only)
18 Years
ALL
No
Sponsors
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Vascutek Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clark J Zeebregts, MD, PhD, Prof
Role: PRINCIPAL_INVESTIGATOR
Universitair Medisch Centrum Groningen (UMCG), Netherlands
Michel MPJ Reijnen, MD, PhD, Prof
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital, Arnhem, Netherlands
Locations
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Epworth Richmond Private Hospital
Melbourne, Victoria, Australia
Hollywood Medical Centre
Perth, Western Australia, Australia
Wilhelminenspital
Vienna, , Austria
Peter Lougheed Centre
Calgary, Alberta, Canada
Rijnstate Hospital
Arnhem, , Netherlands
Medisch Spectrum Twente (MST)
Enschede, , Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen, , Netherlands
Antonius Ziekenhuis
Nieuwegein, , Netherlands
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Frimley Park Hospital
Camberley, , United Kingdom
Imperial College, St Mary's Hospital
London, , United Kingdom
Countries
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Other Identifiers
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FACT-001
Identifier Type: -
Identifier Source: org_study_id