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Clinical Trials in the UK / NCT03180996
Active, not recruiting Observational

Global Fenestrated Anaconda Clinical STudy

NCT03180996 · tracked via the Priya Life Science UK tracker
Sponsor
Vascutek Ltd.
Phase
Observational
Started
2017-09-11
Last updated
2024-12-24

Condition(s) studied

Abdominal Aortic Aneurysm

Investigational drug(s) / intervention(s)

Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System

Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System: Fenestrated Endovascular Aortic Repair (FEVAR)

Study summary

This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal Aortic Aneurysm.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Patients must meet all of the criteria below in order to be eligible for inclusion in the study - 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: Any patient who meets any of the criteria below will be excluded from participation in the study - 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)

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Epworth Richmond Private Hospital Melbourne Victoria
Hollywood Medical Centre Perth Western Australia
Wilhelminenspital Vienna Austria
Peter Lougheed Centre Calgary Alberta
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
Frimley Park Hospital Camberley United Kingdom
Imperial College, St Mary's Hospital London United Kingdom

More Vascutek Ltd. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03180996 on ClinicalTrials.gov ↗ ← All trials in the UK