Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II

Prior treatment

• subject is a woman who is pregnant or nursing (pregnancy test, either urine or blood test must be performed within 7 days prior to the index procedure in woman of child-bearing potential, and must not commit to initiating a pregnancy for 12 weeks after implantation, using effective contraception);
• ST-elevation myocardial infarction in the previous 48 hours;
• concomitant PCI at the same vessel with any device (vessels are considered: left anterior descending, circumflex or right coronary artery);
• previous stent implantation at target vessel (left anterior descending artery; circumflex artery; right coronary artery);

Other illness

• patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus or contrast media, which cannot be adequately pre-medicated;
• culprit lesion stenosis \>99% and/or Thrombolysis In Myocardial Infarction (TIMI) flow \<2;

Lab values

• creatinine clearance \<30 ml/min;
• left ventricular ejection fraction \<30%;

Other

• patients participating in another clinical study;
• life expectancy \<12 months;
• visible thrombus at lesion site;
• target lesion/vessel with any of the following characteristics:
• pre-dilatation of the target lesion not performed or not successful (residual stenosis \>30%);
• severe calcification of the target vessel, at lesion site but also proximally;
• highly tortuous vessel which could impair device delivery to the lesion site following Investigator's judgement;
• bifurcation lesion where side branch treatment is anticipated;
• left main stem stenosis \>50%;
• target lesion is in left main stem
• Lesion is located within asaphenous vein graft

• age \>18 years;
• all patients with a clinical indication to Percutaneous Coronary Intervention (PCI) (stable coronary artery disease or acute coronary syndromes);
• native coronary artery lesion in a vessel with diameter \>2.0 mm and ≦3.5 mm at visual estimation;
• maximum lesion length: 50 mm.
• informed consent to participate in the study.