Sirolimus-coated balloon versus drug-eluting stent in native coronary vessels

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 1130

Inclusion Criteria

age >18 years;
- all patients with a clinical indication to PCI (stable coronary artery disease or acute coronary syndromes);
- native coronary artery lesion in a vessel with diameter >2.0 mm and ?3.0 mm at visual estimation;
- maximum lesion lenght: 40 mm.
- informed consent to participate in the study.

Exclusion Criteria

- patients with known (and untreatable) hypersensitivity or contraindication to aspirin, 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 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);
- 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 TIMI flow <2;
- target lesion/vessel with any of the following characteristics:
- concomitant PCI at the same vessel with any device (vessels are considered: left anterior descending, circumflex or right coronary
artery);
- 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;
- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To verify the non-inferiority of Magic Touch SCB hypothesized in target lesion failure (TLF), a composite of cardiac death, ischemia-driven target lesion revascularization (TLR), target vessel myocardial infarction (MI), at 12 months

Secondary Outcome Measures

Name	Time	Method
-cardiac death;<br>-all-cause death;<br>-Q-wave MI;<br>-any MI;<br>-TLR;<br>-target vessel revascularization;<br>-vessel thrombosis;<br>-bleedings following BARC classification.