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

Fondazione Ricerca e Innovazione Cardiovascolare ETS0 sites1,130 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Fondazione Ricerca e Innovazione Cardiovascolare ETS

•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.

•\- 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: