BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial

Exclusion Criteria

• •ii. In addition, in cases where non-target vessel PCI has occurred 24-72 hours prior to the index procedure, at least 2 sets of cardiac biomarkers must have been drawn at least 6 and 12 hours after the non-target vessel PCI.
• •iii. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling.
• •d. Over 30 days prior to Index Procedure: PCI of non-target lesions performed greater than 30 days prior to index procedure whether or not successful and uncomplicated.
• •5\. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
• •1. STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin) have not peaked.
• •2. PCI within the 24 hours preceding the index procedure.
• •3. Non-target lesion PCI in the target vessel 24 hours to 30 days.
• •4. Planned staged procedures.
• •5. Brachytherapy in conjunction with the index procedure.
• •6. History of stent thrombosis.
• •7. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP.
• •8. Subject is intubated.
• •9. Known LVEF \<30%.
• •10. Relative or absolute contraindication to DAPT for 6 months in non-ACS patients and 12 months in ACS patients (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment).
• •11. eGFR \<30 mL/min
• •12. Hemoglobin \<10 g/dL.
• •13. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
• •14. White blood cell (WBC) count \<3,000 cells/mm3.
• •15. Clinically significant liver disease.
• •16. Active peptic ulcer or active bleeding from any site.
• •17. Bleeding from any site within the prior 8 weeks requiring active medical or surgical attention.
• •18. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath.
• •19. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• •20. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.
• •21. Known allergy to the study stent components cobalt, nickel, chromium, molybdenum, Carbosil®, PBMA, or limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds).
• •22. Known allergy to protocol-required concomitant medications such as aspirin, or DAPT (clopidogrel, prasugrel, ticagrelor), or heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated.
• •23. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduced life expectancy to \<24 months (e.g. cancer, severe heart failure, severe lung disease).
• •24. Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint.
• •25. Women who are pregnant or breastfeeding.
• •26. Women who intend to become pregnant within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure).
• •27. Patient has received an organ transplant or is on a waiting list for an organ transplant.
• •28. Patient is receiving or scheduled to receive chemotherapy within 30 days before or any time after the index procedure.
• •29. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are allowed.
• •30. Unprotected left main lesions ≥30%, or planned left main intervention.
• •31. Bifurcation lesions with planned dual stent implantation.
• •32. Stenting of lesions due to DES restenosis.
• •33. Occlusive thrombus and/or a thrombus requiring thrombectomy in a target vessel
• •34. Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 12 months after the index procedure.