The objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).
Subject is ≥ 18 years and ≤ 80 years of age
Subject has provided written informed consent as approved by the Independent Ethical Committee (IEC) or Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures
Subject is eligible for PCI according to the applicable guidelines
Subject is an acceptable candidate for coronary artery bypass surgery
Subject is hemodynamically stable with documented declining cardiac biomarkers;
Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s)
Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine
Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)
Parallel
Freesolve RMS
DeviceSubject undergoes implantation of Freesolve RMS
Xience DES
DeviceSubject undergoes implantation of Xience DES
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure
The primary endpoint will be Target Lesion Failure (TLF) at 12 months. TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Lesion Revascularization (TLR).
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