First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients

Exclusion Criteria

• •Concomitant Common Iliac Artery aneurysms ≥ 25mm
• •Life expectancy \<2 years
• •Already participating in an investigational drug or device study
• •Known allergy or contraindication to any study device material
• •Coagulopathy or uncontrolled bleeding disorder
• •Ruptured, leaking, inflammatory or mycotic aneurysm
• •Connective tissue diseases (e.g., Marfan Syndrome)
• •Unsuitable vascular anatomy that may interfere with device introduction or deployment, in the opinion of the investigator
• •Aneurysmal or dissected disease of the descending thoracic aorta
• •Previous surgical or EVAR repair for AAA
• •Myocardial infarction and/or major heart surgery ≤ 90 days prior to the procedure
• •Transient Ischemic Attack or stroke ≤ 90 days prior to the procedure
• •Unstable angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia or valvular disease ≤ 30 days prior to the procedure
• •Unable or unwilling to comply with study follow-up requirements
• •Serum creatinine level ≥ 180 µmol/L
• •Patients of childbearing potential who are pregnant or planning to become pregnant during the course of the study
• •Patient has other medical, social or psychological problems that, in the opinion of the investigator, study involvement would not be in their best interest.