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

Inclusion Criteria:

• 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 atvisual estimation;

• maximum lesion length: 50 mm.

• informed consent to participate in the study.

Exclusion Criteria:

• patients with known (and untreatable) hypersensitivity or contraindication toaspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus or contrast media,which cannot be adequately pre-medicated;

• patients participating in another clinical study;

• subject is a woman who is pregnant or nursing (pregnancy test, either urine or bloodtest must be performed within 7 days prior to the index procedure in woman ofchild-bearing potential, and must not commit to initiating a pregnancy for 12 weeksafter implantation, using effective contraception);

• creatinine clearance <30 ml/min;

• left ventricular ejection fraction <30%;

• life expectancy <12 months;

• ST-elevation myocardial infarction in the previous 48 hours;

• visible thrombus at lesion site;

• culprit lesion stenosis >99% and/or Thrombolysis In Myocardial Infarction (TIMI)flow <2;

• target lesion/vessel with any of the following characteristics:

• concomitant PCI at the same vessel with any device (vessels are considered: leftanterior descending, circumflex or right coronary artery);

• pre-dilatation of the target lesion not performed or not successful (residualstenosis >30%);

• severe calcification of the target vessel, at lesion site but also proximally;

• highly tortuous vessel which could impair device delivery to the lesion sitefollowing Investigator's judgement;

• previous stent implantation at target vessel (left anterior descending artery;circumflex artery; right coronary artery);

• 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