Remote Ischemic Conditioning Using the autoRIC

This is a multi-center, randomized, controlled single-blind clinical trial to evaluate the
safety and effectiveness of the autoRIC device to attenuate myocardial injury as measured by
cardiac Troponin I (cTnI) levels in patients undergoing PCI with stent implantation.

Eligible patients that are scheduled for an elective PCI, or unscheduled/non-emergent PCI, or
patients scheduled for a diagnostic catheterization procedure with orders of "treat as
indicated" will be enrolled in the study. Patients will undergo remote ischemic conditioning
with the autoRIC device or the control procedure with the autoRIC Sham device completed ≤ 1
hour prior to balloon or stent inflation. Subjects will have measurements of cTnI levels at
baseline and 4-8 and 12-24 hours post completion of the PCI procedure. Adverse events will be
recorded through study exit for all patients. Patients will be exited from the study after
completion of their 30-day post-procedure telephone follow-up.

Inclusion Criteria:

1. Subject is ≥ 18 years of age

2. Subject is scheduled for elective PCI, or unscheduled but non-emergent PCI, or
diagnostic catheterization with PCI if indicated. For non-elective cases, there must
be at least two troponin levels within the upper limit of normal (ULN), at least 6
hours apart prior to the index procedure

3. Subject is willing and capable of providing written informed consent

4. If the subject is a woman of childbearing potential, she must have had a negative
pregnancy test within 24 hours of the study procedure

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