Global Fenestrated Anaconda Clinical STudy
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Trial details
- Who runs it
- Vascutek Ltd.
- Trial code
- NCT03180996
- Record updated
- 24 December 2024
- Original description
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.Read full original descriptionShow less
A Prospective, Global, Multicentre, Real World Outcome Study of Fenestrated Endovascular Aneurysm Repair Using the Fenestrated Anaconda™ Device
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.
Inclusion: 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.
Exclusion: 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).