BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable MAGnesium Scaffold (Freesolve) in the Treatment of Subjects With Long de Novo Lesions in Native Coronary Arteries: BIOMAG-LL
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.
‣ Clinical Inclusion Criteria
• 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, cangrelor or ticlopidine
• Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to enrollment)
• Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study
‣ Angiographic Inclusion Criteria
• 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 2.7-4.2 mm by visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT)
• Target lesion must be \>28 mm and ≤ 38 mm in length by operator visual estimation, which may be assisted by QCA / IVUS / OCT, 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