This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anacondaâ„¢ system, and is essentially a post-market study. The Vascutek Fenestrated Anacondaâ„¢ system is a custom made device used for the treatment of Abdominal Aortic Aneurysm.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient is aged 18 years or over on the date of consent
✓. Patient is willing and able to comply with all study procedures and study follow-up visits
✓. Patient is willing and able to give written informed consent to participate in study
✓. 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
✓. Patient is anatomically suitable for a bifurcated Fenestrated Anaconda™ device
Exclusion criteria
✕. Patient has a life expectancy \< 2 years, as judged by the Investigator
✕. Patient has psychiatric or other condition that in the opinion of the Investigator may limit their ability to comply with study procedures
✕. Patient is participating in another clinical study which in the opinion of the Investigator could influence the outcomes of this study
✕. Patient has a known allergy to any device component (polyester, nitinol, nickel)
✕. Patient has a coagulopathy or uncontrolled bleeding disorder
✕. Patient has a ruptured, leaking or mycotic aneurysm
✕. Patient has a serum creatinine (S-Cr) level \> 2.0 mg/dL (177 µmol/L)
What they're measuring
1
Proportion of patients who experience Treatment Success.