Last updated on November 2018

Global Fenestrated Anaconda Clinical sTudy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Abdominal aortic aneurysm
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 mol/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)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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