SOLVE-ACS: Bioresorbable Magnesium-Stents Magmaris in ACS Lesions

Exclusion Criteria

• •Currently participating within a FIM or RCT and primary endpoint is not reached yet.
• •Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidine, prasugrel, heparin or any other anticoagulant /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs or the Magmaris materials including Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum that cannot be adequately pre-medicated.
• •Renal insufficiency with serum-creatinine ≥ 2.5 mg/dl or subjects on dialysis.
• •Known systolic heart failure with left-ventricular ejection fraction (LV-EF≤ 30 %).
• •Active sepsis.
• •Presence of cardiogenic shock or heart failure requiring intubation, inotropes, intravenous diuretics or mechanical circulation support.
• •Refractory ventricular arrhythmia requiring pharmacologic or defibrillator therapy.
• •Patients under immunosuppressive therapy.
• •Unprotected significant left main- stenosis.
• •ACS with culprit lesion in a bypass graft or ACS caused by stent/BVS-thrombosis or stent/BVS-restenosis.
• •ACS caused by left main coronary artery disease or an ostial target lesion (within 5.0 mm of vessel origin).
• •Culprit lesion involves a side branch ≥2.0 mm in diameter (bifurcation lesion).
• •Culprit lesion located within a true vessel bifurcation (including side branch \> 2mm) which requires bifurcation-treatment according to the investigator's discretion.
• •Extent and severity of CAD is such that investigator believes it is likely that bypass surgery will be required within 1 year of enrollment.
• •Severe calcification or extreme tortuosity of vessel with "culprit lesion".
• •Culprit lesion with very distal location.
• •Culprit vessels with "low or no-reflow phenomenon" (TIMI 0,I,II) after mechanical recanalization or pre-dilatation using a non-compliant balloon with 1:1 balloon-to-artery ratio.
• •Culprit lesions with a length ≥ 21 mm or within vessels with reference diameter≤ 2.7mm or ≥ 3.7 mm by QCA or by visual estimation.
• •Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of Magmaris and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections), by visual estimation.
• •Non-MCG-safe metal implants
• •Inability or unwillingness to lie flat for 5 minutes and follow breathing commands