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

Launched by FONDAZIONE RICERCA E INNOVAZIONE CARDIOVASCOLARE ETS · May 18, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a special type of balloon called the Sirolimus-coated Balloon (SCB) compared to a commonly used stent called the everolimus-eluting stent (EES) in treating patients with coronary artery disease. The trial aims to see which treatment works better for people with narrowed arteries, which can lead to heart problems. The study is open to patients aged 18 and older who need a procedure to open blocked coronary arteries, and it is currently recruiting participants.

If you or a loved one might be eligible, you would need to have a specific type of blockage in your coronary arteries that meets certain size requirements. Participants will have to provide informed consent, meaning they understand the study and agree to take part. Throughout the trial, participants will receive either the SCB or the EES treatment, and your doctor will closely monitor your progress. It's important to know that certain conditions might exclude you from participating, such as severe kidney issues or recent heart attacks. Overall, this study aims to find out which treatment is more effective and could help improve care for people with heart conditions.

Gender

ALL

Eligibility criteria

• 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 at visual estimation;
• • maximum lesion length: 50 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 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: 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
• • Lesion is located within asaphenous vein graft