Evaluation of the Bifurcated Multilayer Flow Modulator for the Treatment of Abdominal Aortic Aneurysm

Ki vehet részt

• Patients must meet ALL of the following criteria:
• Age over 18
• Life expectancy > 12 months
• Aortic aneurysms involving iliac arteries
• Healthy proximal and distal landing zone
• Adequate arterial access
• Healthy branches and collaterals (no stenosis or previously treated by angioplasty)
• Informed consent understood, signed and patient agrees to all follow-up visits

Ki nem vehet részt

• Prior all surgical procedure within 30 days unless procedure is in preparation for device implantation or planned within 30 days post stent deployment
• Contraindications to the anticoagulant or/ and antiplatelet medications
• Patient with undergoing or planned chemotherapy
• The use of the MFM® with stent-grafts or previously implanted stent-grafts
• Patients will be excluded if ANY of the following conditions apply:
• Myocardial infarction or cerebral vascular accident within 6 weeks of treatment
• Presence/suspicion of connective tissue disorders, for example, Marfan or Ehlers-Danlos etc
• Allergic reaction to a contrast agent
• History of bleeding disorder (coagulopathy) or thrombophilia
• Presence/suspicion of infection (for example: mycotic aorta)
• Aneurysm rupture, impending or contained rupture
• Aortic dissection
• Aortic root aneurysm
• Pleural effusion
• Shaggy aorta
• Takayasu's arteritis
• Pregnant or breastfeeding woman
• Patients included in another clinical study