ABSORB Clinical Investigation, Cohort B

Exclusion Criteria

• •6. Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure
• •7. Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done \> 6 months prior to or if planned to be done 6 months after the index procedure
• •1. Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure
• •2. The patient is currently experiencing clinical symptoms consistent with AMI
• •3. Patient has current unstable arrhythmias
• •4. Patient has a known left ventricular ejection fraction (LVEF) \< 30%
• •5. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
• •6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
• •7. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
• •8. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
• •9. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated
• •10. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
• •11. Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a white blood cell count of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
• •12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
• •13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• •14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
• •15. Patient has had a significant GI or urinary bleed within the past six months
• •16. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
• •17. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
• •18. Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
• •19. Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation)
• •20. Patient has received brachytherapy in any epicardial vessel (including side branches)
• •1. Target lesion(s) meets any of the following criteria:
• •1. Aorto-ostial location (within 3 mm)
• •2. Left main location
• •3. Located within 2 mm of the origin of the LAD or LCX
• •4. Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and \> 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
• •5. Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion \> 40% stenosed by visual estimation or side branch requiring predilatation
• •6. Total occlusion (TIMI flow 0), prior to wire crossing
• •7. Excessive tortuosity proximal to or within the lesion
• •8. Extreme angulation (≥ 90%) proximal to or within the lesion
• •9. Heavy calcification
• •10. Restenotic from previous intervention
• •2. The target vessel contains visible thrombus
• •3. Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)
• •4. Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)