Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms

Exclusion Criteria

• •1. Subject is pregnant or lactating
• •2. Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
• •3. Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery
• •4. Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging
• •5. Subject has a lesion that cannot be crossed by a guide wire
• •6. Proximal neck cannot increase by more than 10% over 15mm or more than 7% over 10mm; i.e., no trapezoidal necks
• •7. Subject has severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction \< 20%, or recent diagnosis of Congestive Heart Failure (CHF)
• •8. Subject has had a stroke or myocardial infarction within 6 months of the planned treatment date
• •9. Subject has chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
• •10. Subject has an active systemic infection or is suspected of having an active systemic infection (e.g.,AIDS/HIV, sepsis)
• •11. Subject is morbidly obese (more than 100% over the ideal body weight or as defined by institutional standards) or has other clinical conditions that severely compromise or impair x-ray visualization of the aorta
• •12. Subject has connective tissue disease (e.g., Marfan's syndrome)
• •13. Subject has a mycotic aneurysm
• •14. Subject has significant or circumferential calcification or mural thrombus in the proximal aortic neck
• •15. Subject has significant or circumferential calcification or mural thrombus in the distal iliac landing zone
• •16. Subject has significant or circumferential calcification or mural thrombus within the treatment length, which may adversely impact device patency
• •17. Subject has a blood coagulation disorder or bleeding diathesis, the treatment for which cannot be suspended pre- and post-repair
• •18. Subject is in acute or chronic renal failure (creatinine \> 2.5 mg/dL) unless subject is stable on dialysis
• •19. Subject has less than two-year life expectancy as evidenced by factors prohibiting major medical intervention (e.g., presence of malignancy, severe cardiopulmonary disease, etc.)
• •20. Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure
• •21. Subject is confronted with other medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up. These reasons must be documented. An example may include adherence to a theological or personal doctrine with aversion or opposition to blood transfusion.
• •22. Subject has had a prior AAA repair (endovascular or surgical)
• •23. Subject has an untreatable allergy or sensitivity to contrast media, nitinol/nickel, or polyester
• •24. Subject has undergone other major surgical or medical intervention within 45 days of the planned procedure or is planning to undergo other major surgical or medical intervention within 45 days post implantation (e.g., Coronary Artery Bypass Graft (CABG), organ transplantation, renal stenting, etc.)