BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV

Exclusion Criteria

• •1. Pregnant and/or breast feeding females or females who intend to become pregnant during the time of the registry
• •2. Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, heparin or any other anticoagulant/antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs; or the scaffold materials including Magnesium, Yttrium, Neodymium, Zirconium,Gadolinium, Dysprosium, Tantalum that cannot beadequately pre-medicated
• •3. Subjects on dialysis
• •4. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST Elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment
• •5. Documented left ventricular ejection fraction (LVEF) \<30%
• •6. Restenotic target lesion
• •7. Thrombus in target vessel
• •8. Target lesion is located in or supplied by a diseased (defined as vessel irregularity per angiogram and \>20% stenosed lesion by visual estimation) arterial or venous bypass graft
• •9. Left main coronary artery disease
• •10. Ostial target lesion (within 5.0 mm of vessel origin)
• •11. Target lesion involves a side branch ≥2.0 mm in Diameter
• •12. Target vessel (including side branches) has second lesion which requires treatment according to the investigator's discretion
• •13. Unsuccessful pre-dilatation, defined as residual Stenosis rate more than 20% measured by QCA and / or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
• •14. Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
• •15. Currently participating in another study and Primary endpoint is not reached yet.
• •16. Planned interventional treatment of any target or nontarget vessel
• •Participating Countries
• •Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Malaysia, New Zealand, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, United Kingdom