Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms

Exclusion Criteria

• •1. Under the age of 18 years
• •2. Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
• •3. Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
• •4. Willing to participate in a sponsor-investigator IDE with access to a non-physician modified endovascular prostheses at the investigational site
• •5. Willing to travel to an investigational site with access to a non-physician modified endovascular prosthesis
• •6. Unwilling or unable to comply with the follow-up schedule
• •7. Inability or refusal to give informed consent by patient or legal representative
• •8. Patient is pregnant or breastfeeding
• •9. Life expectancy \< 2-years despite successful aneurysm exclusion
• •10. Free rupture with hemodynamic instability
• •11. Ongoing infection
• •12. Diagnosis of, or suspected connective tissue disease
• •13. Known sensitivities or allergies to the materials of construction of the devices
• •14. Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• •15. Uncorrectable coagulopathy
• •16. Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
• •17. Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
• •18. Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
• •19. Systemic or local infection that may increase the risk of endovascular graft infection
• •20. Leaking or free rupture of aneurysm associated with hemodynamic instability.
• •21. Baseline creatinine greater than 3.0 mg/dL
• •22. Known history of, or suspected connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
• •1. Inadequate femoral or iliac access compatible with the required delivery systems, not amenable to open surgical or endovascular conduit placement
• •2. Absence of a non-aneurysmal aortic segment for proximal seal zone with:
• •* A diameter measured outer wall to outer wall of no greater than 38mm and no less than 21 mm;
• •* Parallel aortic wall with \<20% diameter change and without significant calcification and/or thrombus in the selected area of seal zone
• •3. Visceral vessel anatomy not compatible with physician-modified Zenith® Alpha Endovascular Graft due to excessive occlusive disease or small size not amenable to stent graft placement
• •4. Unsuitable distal iliac artery fixation site and anatomy:
• •* Common iliac artery fixation site diameter measured outer wall to outer wall on a sectional image (CT) \<8.0 mm with inability to perform open surgical conduit
• •* Iliac artery diameter measured outer wall to outer wall on a sectional image (CT) \>21 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft
• •* Iliac artery distal fixation site \<10 mm in length
• •* Inability to preserve at least one hypogastric artery