The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de Novo Native Coronary Artery Lesions

Exclusion Criteria

• •1. Acute myocardial infarction with Killip Class III and IV
• •2. Acute myocardial infarction requiring resuscitation
• •3. Acute myocardial infarction requiring IABP or ventilation support
• •4. Patient had fibrinolysis prior to PCI
• •5. Patient has current unstable ventricular arrhythmias
• •6. Patient has a known left ventricular ejection fraction (LVEF) \< 30%
• •7. Patient has received a heart transplant or any other organ transplant or is on a waiting list for an organ transplant
• •8. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
• •9. Patient is receiving immunosuppression therapy, other than steroids or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
• •10. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, Novolimus, Sirolimus, Rivaroxaban, Argatroban, CoCr alloys, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
• •11. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors
• •12. Patient has severe renal dysfunction (CKD IV or V, eGFR \<30) or is on dialysis
• •13. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
• •14. Patient has had a significant GI or urinary bleed within the past six months
• •15. Women of childbearing potential (unless they have a negative pregnancy test within 7 days of index procedure), or women who are pregnant or nursing
• •16. Patient has other medical conditions or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation, or be associated with a limited life expectancy (i.e., less than one year)
• •17. Patient is already participating in another clinical study which has not reached the primary endpoint (long-term follow-up or observational studies are permitted)
• •18. Patient with vessel rupture and/or visible pericardial effusion
• •19. Target lesion aorto-ostial location or within 5mm of the origin of the vessel (LAD, LCX, RCA)
• •20. Target lesion is severely calcified and/or requires use of rotational atherectomy or cutting balloon, the use of shockwave or scoring balloon is allowed
• •21. Target Lesion located in the Left Main artery
• •22. Target Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
• •23. Target Lesion involves a bifurcation \>2.5 mm, or which requires a planned 2 or more stent technique
• •24. Previous placement of a stent within 10 mm of a target lesion
• •25. Another clinically-significant lesion (\> 50%) is located in the same major epicardial vessel as a target lesion
• •26. Target vessel was previously treated with any type of PCI \< 6 months prior to index procedure
• •27. Unsuccessful or complicated PCI in a non-target vessel \< 48 hours prior to index procedure
• •28. Target vessel has a planned staged PCI ≤ 6 months after the index procedure
• •29. Target vessel was previously treated with any type of PCI \< 6 months prior to index procedure
• •30. Patient with planned staged PCI within 90 days after study procedure
• •31. Patients who have a non-target lesion treated during the study procedure