Remote Ischemic Conditioning Using the autoRIC

Exclusion Criteria

• •1. Subject requires emergency PCI (i.e., PCI for evolving or ongoing STEMI/NSTEMI)
• •2. Subject has an elevated troponin level (cTnI or T) \> ULN at baseline, based on lab results obtained from the treating institution
• •3. Subject is scheduled to undergo PCI with the use of Propofol
• •4. Subject has a recent history of drug treatment with potassium channel activators (e.g., Nicorandil) or potassium channel blockers (e.g., sulfonylureas) during the last 7 days prior to baseline
• •5. Subject had STEMI during the last 4 weeks prior to baseline. (Note: NSTEMI in the last 4 weeks prior to baseline is allowed if the baseline troponin is ≤ ULN.)
• •6. Underwent a CABG in the last 4 weeks prior to baseline
• •7. Had a PCI within the last 7 days prior to baseline
• •8. Subject has a life expectancy \< 6 months
• •9. Subject has NYHA Class IV or decompensated heart failure
• •10. Subject has peripheral vascular disease requiring intervention during the index hospitalization or within 4 weeks post-procedure
• •11. Subject has either serum creatinine \>2 times the age-appropriate upper limit of normal, a glomerular filtration rate (GFR) of \< 30 mL/min/1.73m2 or requires dialysis
• •12. Subject has systolic blood pressure \> 200 mmHg
• •13. Subject is currently being treated with systemic oral or I.V. steroids
• •14. Subject has a known bleeding disorder or known abnormality of blood flow to the limb to be treated
• •15. Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre-existing traumatic injury to the limb to be treated
• •16. Subject is scheduled for a PCI procedure to treat a known Chronic Total Occlusion (CTO) lesion
• •17. Subject is currently participating in or is planning to participate in another investigational drug or device trial, prior to the 30-day follow-up visit. (Note: Observational studies or post-approval studies/ registries, are allowed.)
• •18. Planned (staged) post-index procedure intervention within 30 days (i.e., PCI of non-target lesions in any vessel or CABG). (Note: Planned revascularization (PCI or bypass) of a non-target lesion \>30 days following the index procedure is allowed.)
• •19. Any cardiac surgical procedure planned within 30 days post-enrollment