Study of Vascular Healing With the Combo Stent Versus the Everolimus Eluting Stent in ACS Patients by Means of OCT (REMEDEE-OCT)

Inclusion Criteria

1. age ≥18 and ≤ 80 years
2. ST or Non-ST-segment elevation MI (assumed to be a type 1)
3. Acceptable CABG candidate
4. Patient willing to comply with specified follow-up
5. Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent
6. Single de novo or non-stented restenotic lesion in a native coronary artery
7. Patients with 2-vessel coronary disease, may have undergone successful treatment (<20% diameter stenosis by visual estimate) of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment. Any non-target vessel or lesion intended to be treated during the index procedure or follow-up, cannot be an unprotected left main, ostial lesion, chronic total occlusion, heavily calcified, bifurcation, vein grafts, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty; 8. Target lesion (maximum length is 20 mm by visual estimate) to be covered by a single stent of max 23 mm (stent coverage incl at least 3 mm of healthy vessel is recommended). The lesion length to be measured after pre-dilation 9. Reference vessel diameter ≥2.5 to ≤ 3.5 mm by visual estimate 10. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected 11. Target lesion ≥50% and <100% stenosed by visual estimate

Exclusion Criteria

1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
2. Impaired renal function or on dialysis
3. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC<3,000 cells/mm3
4. Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
5. Patient requires low molecular weight heparin (LMWH) treatment postprocedure or has received a dose of LMWH ≤8 hours prior to index procedure
6. Patient has received any organ transplant or is on a waiting list for any organ transplant;
7. Patient has other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (<1 year)
8. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus and/or contrast sensitivity that cannot be adequately pre-medicated
9. Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies
10. Patient presents with cardiogenic shock
11. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion;
12. Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
13. Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up
14. Unprotected left main coronary artery disease with ≥50% stenosis
15. Ostial target lesion(s)
16. Totally occluded target vessel (TIMI flow 0)
17. Calcified target lesion(s) which cannot be successfully predilated
18. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
19. Target lesion involving bifurcation with a side branch ≥2.0 mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require intervention of diseased side branch
20. A significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single stent
21. Diffuse distal disease to target lesion with impaired runoff
22. Pre-treatment with devices other than balloon angioplasty
23. Prior stent within 10 mm of target lesion
24. Intervention (PCI or bypass) of any lesion in the target vessel performed within the previous 6 months
25. Intervention (PCI or bypass) of another lesion in a non-target vessel performed within 30 days prior to the index
26. Planned intervention of another lesion (target vessel or non-target vessel) within 30 days.