DESyne X2 Post Market Follow-up Study

Exclusion Criteria

• •1. The patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor, heparin/bivalirudin, mTOR inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated
• •2. Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing
• •3. Previous placement of a stent within 10 mm distal to the target lesion
• •4. Previous placement of a stent proximal to the target lesion
• •5. Total occlusion or \< TIMI 1 coronary flow in the target vessel
• •6. The proximal target vessel or target lesion is severely calcified by visual assessment
• •7. Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the left anterior descending or left circumflex
• •8. Lesion involvement of a significant side branch (branch diameter \> 2 mm) that would be covered by stenting
• •9. High probability that treatment other than PTCA or stenting will be required for treatment of the same lesion
• •10. The target lesion, or the target vessel proximal to the target lesion, contains thrombus
• •11. The patient has suffered a myocardial infarction within the past 72 hours and the CK or CK-MB has not returned to normal at the time of the index procedure
• •12. The patient is a recipient of a heart transplant
• •13. The patient has extensive peripheral vascular disease that precludes safe sheath insertion or extreme anti-coagulation
• •14. The patient is currently participating in another investigational device or drug study that has not completed the primary follow-up phase
• •15. Patients who are unable or unwilling to cooperate with study procedures