A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)

Exclusion Criteria

• •1. Vascular anatomy in which the placement of the stent-graft will cause occlusion of both internal iliac arteries or necessitates surgical occlusion of both internal iliac arteries;
• •2. Subject has one of the following:
• •1. Aneurysm sac rupture or leaking abdominal aortic aneurysm;
• •2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm;
• •3. Clinically significant acute vascular injury due to trauma;
• •3. Significant aortic or iliac mural thrombus, plaque or calcification that would compromise fixation and seal of the device;
• •4. A conical aortic neck defined as \>3mm distal increase over a 10mm length in the planned seal zone;
• •5. Thoracic aortic aneurysm ≥45mm;
• •6. Any aortic dissection;
• •7. Morbid obesity (BMI \>40.0 kg.m2) or other clinical conditions that limit required imaging studies or visualization of the aorta;
• •8. Renal insufficiency (Creatinine \> 2.0mg/dL) or subject on renal dialysis;
• •9. Known allergy or intolerance to nickel titanium (nitinol) , Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE);
• •10. Known contraindication to undergoing angiography or anticoagulation (e.g. contrast allergies which cannot be treated);
• •11. Connective tissue disorder (such as Marfan's Syndrome or Ehlers-Danlos Syndrome);
• •12. Coagulopathy, bleeding disorder, or other hypercoagulable state;
• •13. Organ transplant recipient or subject requiring systemic immunosuppressant therapy;
• •14. Cerebral vascular accident (CVA), MI, or intracranial bleeding within 3 months prior to the procedure;
• •15. Active infection or chronic systemic illness at the time of index procedure that may interfere with the study objectives;
• •16. Major surgical procedure within 1 month prior to the index procedure or pre-planned within 1 month afterwards;
• •17. Co-existing condition with a life expectancy of less than 2 years at time of procedure;
• •18. Current or planned participation in any other investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation;
• •19. Existing AAA surgical graft and/or a AAA stent-graft system;
• •20. Other medical, social, or psychological issues that in the opinion of the investigator preclude the subjects from receiving this treatment, and the procedures and evaluations pre- and posttreatment.