BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve®) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries: BIOMAG-II: A Randomized Controlled Trial
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
• Subjects with stable or unstable angina pectoris, documented silent ischemia/abnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion
• Note: STEMI patients may be eligible for the study for treatment of selected non-culprit lesions, if:
⁃ Subject and target lesion(s) meet all inclusion and no exclusion criteria and consent occurs at least ≥ 72 hours after successful treatment of the culprit lesion(s) \[lesion(s) causing the acute STEMI\];
⁃ 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)
• Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study
• Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries
• Target vessel must have a reference diameter between 2.5-4.2 mm by visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT)
• Target lesion must be ≤28mm in length by operator visual estimation, which may be assissted by QCA / IVUS / OCT, (or \< 20 mm for target lesion(s) to be treated with a study device \< 3.0 mm in diameter) and should be amenable to treatment with a single study device
• Target lesion stenosis ≥ 50% and \< 100% by operator visual estimation, which may be assisted by QCA / IVUS / OCT. Target lesion stenosis \< 70% by visual estimation, should have clinical justification for treatment as per local standards.
• Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1