European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms

INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years postprocedure. Up to 25 sites in Europe may participate. Subjects will be enrolled and followed at 1 month and 6 month post-procedure and annually up to 5 years.

Inclusion criteria

• Male or Female age 18 years or older
• Femoral access vessels should be adequate to fit the selected delivery system
• Proximal neck length ≥ 10mm
• Aortic neck diameters ≥ 17mm and ≤ 31mm
• Aortic neck suitable for suprarenal fixation
• Infrarenal and suprarenal neck angulation ≤ 60°
• Iliac fixation length ≥ 15mm
• Iliac diameters ≥ 7mm and ≤ 22mm
• Minimum overall AAA treatment length (proximal landing location to distal landing location) ≥ 128mm
• Morphology suitable for aneurysm repair
• Provide written informed consent and as applicable written confidentiality authorization prior to initiation of study procedures
• Subject is willing to comply with the specified follow-up evaluation schedule

Exclusion criteria

• Subject has one of the following:

• Aneurysm sac rupture or leaking abdominal aortic aneurysm
• Mycotic, dissecting, or inflammatory abdominal aortic aneurysm
• Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE)
• Known contraindication to undergoing angiography or anticoagulation
• Existing AAA surgical graft and/or a AAA stent-graft system
• Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial