A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION)

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

Inclusion criteria

• Subject is a male or infertile female > 18 years of age
• Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures.
• Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.
• Subject has at least one of the following:

• Abdominal aortic aneurysm ≥4.5 cm in women or ≥ 5 cm in men in diameter
• Aneurysm, which is >4 cm and which has increased in size by 0.5 cm within 6 months
• The maximum aortic diameter is ≥1.5 times that of the reference aortic diameter
• Saccular aneurysm
• Subject has access vessel size compatible with vascular access techniques and potential accessories used with delivery profile of 14Fr
• Subject aortic aneurysm neck is ≥15 mm in length
• Subject iliac landing zone≥10mm in length
• Subject has distal iliac landing sites with diameter ranges of 9-18mm
• Subject proximal aortic attachment is between 20-27 mm in diameter.
• Subject has a minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 140 mm.
• Subject is willing to comply with all specified follow-up evaluations.

Exclusion criteria

• Subject has one of the following:

• a dissecting or inflammatory aneurysm
• acutely ruptured aneurysm
• pararenal or leaking aneurysm
• The supra-renal aorta at 2cm above the lowest renal aorta is not more than the nominal diameter of the aortic bifurcate prosthesis
• Aortic length (lowest renal artery origin to the aortic bifurcation) of <8.7 cm
• Circumferential thrombosis and/or calcification ≥50% in the aortic and iliac landing zones
• Circumferential thrombosis and/or calcification ≥50% in the supra-renal aorta
• Subject has aneurysm neck angulations that are >60° in the supra-renal and/or infra-renal locations
• Aortic bifurcation ≤18mm in diameter
• Acute vascular injury due to trauma
• Subject has a known allergy to contrast medium
• Subject has known allergy to nitinol, PET or PTFE
• Subject has a need for emergent surgery
• Subject has a contraindication to undergoing angiography
• Subject has a thoracic aortic aneurysm that requires treatment
• Subject has Infra-renal aortic dissection
• Subject has an Iliac anatomy which would require occlusion of both internal iliac arteries
• 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
• Subject has unstable angina as defined by Braunwald angina classification
• Subject has morbid obesity (BMI of >40.0) or other clinical conditions that severely inhibit visualization of the aorta
• Subject has connective tissue disease (e.g., Marfan's or Ehler's-Danos syndrome)
• Subject has known bleeding or hypercoagulable disorder
• Subject has contraindication for anticoagulation
• Subject with Stroke or MI or intracranial bleeding within 3 months prior to the procedure
• Subject with renal insufficiency (creatinine > 2.0 mg/dl)
• Subject has known or suspected active infection at the time of the index procedure (for ex. Pneumonia, acute virus infection, contaminated wounds etc)
• Subject is currently taking systemic immunosuppressant therapy
• Subject had a major surgical procedure within 30 days prior to procedure or planned within 30 days post procedure
• Subject has a life expectancy less than 2 years
• Subject is currently participating in another research study involving an investigational device or new drug
• 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
• Subject with an existing AAA surgical graft and/or a AAA stent-graft system