Global Fenestrated Anaconda Clinical STudy

Ki vehet részt

• Patients must meet all of the criteria below in order to be eligible for inclusion in the study -
• 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; 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

Ki nem vehet részt

• Patient has had a previously inserted endovascular stent in the abdominal aorta
• Patient has psychiatric or other condition that in the opinion of the Investigator may limit their ability to comply with study procedures
• Patient has a known allergy to any device component (polyester, nitinol, nickel)
• Patient has a coagulopathy or uncontrolled bleeding disorder
• Patient has a connective tissue disease (e.g. Marfan Syndrome)
• Patient has a serum creatinine (S-Cr) level > 2.0 mg/dL (177 µmol/L)
• Patient has a life expectancy < 2 years, as judged by the Investigator
• Any patient who meets any of the criteria below will be excluded from participation in the study -
• Patient is participating in another clinical study which in the opinion of the Investigator could influence the outcomes of this study
• Patient has a ruptured, leaking or mycotic aneurysm
• Patient has had CVA or MI within three months of enrolment or treatment
• Patient is pregnant (female of childbearing potential only)