a multicenter, open label, prospective, non-randomized study of incraft™ in subjects with aaa (innovation)

Conditions: Abdominal Aortic Aneurysms

Summary: this study is a multi-center prospective, open label, non-randomized investigation of incraft™ in subjects with abdominal aortic aneurysms. the study will enroll up to 60 subjects in up to 7 sites in germany and italy.

this study is a multi-center prospective, open label, non-randomized investigation of incraft™ in subjects with abdominal aortic aneurysms. the study will enroll up to 60 subjects at 7 sites in germany and italy. all treated subjects will be evaluated at 1 month, 3 months (if applicable), 6 and 12 months, and annually for a total of 5 years post-procedure. an interim analysis will be conducted after the 25th enrolled subject reaches the 30-day follow up visit

Eligibility criteria:
inclusion criteria: 1. subject is a male or infertile female \> 18 years of age 2. subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures. 3. subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm. 4. subject has at least one of the following: 1. abdominal aortic aneurysm ≥4.5 cm in women or ≥ 5 cm in men in diameter 2. aneurysm, which is \>4 cm and which has increased in size by 0.5 cm within 6 months 3. the maximum aortic diameter is ≥1.5 times that of the reference aortic diameter 4. saccular aneurysm 5. subject has access vessel size compatible with vascular access techniques and potential accessories used with delivery profile of 14fr 6. subject aortic aneurysm neck is ≥15 mm in length 7. subject iliac landing zone≥10mm in length 8. subject has distal iliac landing sites with diameter ranges of 9-18mm 9. subject proximal aortic attachment is between 20-27 mm in diameter. 10. subject has a minimum overall aaa treatment length (from lowest renal artery to distal landing zone) of 140 mm. 11. subject is willing to comply with all specified follow-up evaluations. exclusion criteria: 1. subject has one of the following: 1. a dissecting or inflammatory aneurysm 2. acutely ruptured aneurysm 3. pararenal or leaking aneurysm 2. the supra-renal aorta at 2cm above the lowest renal aorta is not more than the nominal diameter of the aortic bifurcate prosthesis 3. aortic length (lowest renal artery origin to the aortic bifurcation) of \<8.7 cm 4. circumferential thrombosis and/or calcification ≥50% in the aortic and iliac landing zones 5. circumferential thrombosis and/or calcification ≥50% in the supra-renal aorta 6. subject has aneurysm neck angulations that are \>60° in the supra-renal and/or infra-renal locations 7. aortic bifurcation ≤18mm in diameter 8. acute vascular injury due to trauma 9. subject has a known allergy to contrast medium 10. subject has known allergy to nitinol, pet or ptfe 11. subject has a need for emergent surgery 12. subject has a contraindication to undergoing angiography 13. subject has a thoracic aortic aneurysm that requires treatment 14. subject has infra-renal aortic dissection 15. subject has an iliac anatomy which would require occlusion of both internal iliac arteries 16. subject has congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. such abnormalities should be evaluated (e.g. angiography or ct) prior to treatment 17. subject has unstable angina as defined by braunwald angina classification 18. subject has morbid obesity (bmi of \>40.0) or other clinical conditions that severely inhibit visualization of the aorta 19. subject has connective tissue disease (e.g., marfan's or ehler's-danos syndrome) 20. subject has known bleeding or hypercoagulable disorder 21. subject has contraindication for anticoagulation 22. subject with stroke or mi or intracranial bleeding within 3 months prior to the procedure 23. subject with renal insufficiency (creatinine \> 2.0 mg/dl) 24. subject has known or suspected active infection at the time of the index procedure (for ex. pneumonia, acute virus infection, contaminated wounds etc) 25. subject is currently taking systemic immunosuppressant therapy 26. subject had a major surgical procedure within 30 days prior to procedure or planned within 30 days post procedure 27. subject has a life expectancy less than 2 years 28. subject is currently participating in another research study involving an investigational device or new drug 29. other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment 30. subject with an existing aaa surgical graft and/or a aaa stent-graft system

Keywords: abdominal aortic aneurysm aaa safety performance stent graft system first in human endovascular repair