The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.
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, cangrelor or ticlopidine
Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to enrollment)
Single group
Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
DeviceSubjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold
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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