Custom-made stent grafts for complex aortic aneurysms that standard devices cannot treat

Who can take part

• A patient may be suitable for inclusion in the study if the patient has at least one of the following:; Aortic or aortoiliac aneurysm with diameter ≥5.5 cm; Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms; General Inclusion Criteria; <!-- -->; Cannot be treated with a currently available non-modified approved device; Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device; At least 18 years of age; Not pregnant or breastfeeding; Willing and able to comply with five years of follow-up; Willing and able to provide informed consent prior to enrollment; No systemic or local infection that may increase the risk of endovascular graft infection; High risk for open surgical repair based on any of the factors below:; Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery b. Physiologic i. ASA Category III or higher ii. Age >70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD

Who cannot take part

• Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) <7.0 mm at any point along access length (prior to deployment)
• Exclusion Criteria Medical Exclusion Criteria; Cultural objection to receipt of blood or blood products; Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol; Anaphylactic reaction to contrast that cannot be adequately pre-medicated; Uncorrectable coagulopathy; Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina); Patient has active malignancy with life expectancy of less than 2 years; Patient has life expectancy less than two years; Anatomical Exclusion Criteria
• Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
• Proximal neck length ≤25 mm
• Proximal neck, measured outer wall to outer wall on a sectional image (CT); For use of Zenith Flex: diameter >32 mm or <18 mm; For use of Zenith TX2: diameter >38 mm or <24 mm (for proximal and distal neck diameter)
• Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
• Proximal neck diameter change over the length of the proximal seal zone >4 mm
• Proximal seal site with a circumferential thrombus/atheroma
• Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) >21 mm at distal fixation site
• Iliac artery distal fixation site <10 mm in length
• Non-bifurcated segment of any artery to be stented < 15 mm in length
• Artery to be stented with a maximum diameter <3 mm or >10 mm at the vessel ostium
• Inability to maintain at least one patent hypogastric artery