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Comparing Sirolimus-coated balloons to drug-eluting stents for coronary artery disease

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

Not applicable Interventional Fondazione Ricerca e Innovazione Cardiovascolare ETS · NCT04893291

This study is testing whether a special balloon treatment is better than a standard stent for people with narrowed coronary arteries.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1820 (estimated)
Ages18 Years and up
SexAll
SponsorFondazione Ricerca e Innovazione Cardiovascolare ETS Academic / other
Locations25 sites (Dhaka and 24 other locations)
Trial IDNCT04893291 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy of the Magic Touch Sirolimus Coated Balloon (SCB) compared to the everolimus-eluting drug-eluting stent (EES) in treating native coronary artery disease. It is an international, multicentric, open-label, randomized trial that will enroll patients with coronary vessels between 2.0 mm and 3.5 mm in diameter. The study will assess outcomes related to the treatment of coronary artery stenosis and aims to provide insights into the effectiveness of SCB in comparison to the established EES. Participants will be monitored for their response to the interventions over a defined period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years with stable coronary artery disease or acute coronary syndromes requiring percutaneous coronary intervention.

Not a fit: Patients with known hypersensitivity to the study medications or those with severe renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with coronary artery disease, potentially reducing complications associated with stenting.

How similar studies have performed: Previous studies have shown promising results with drug-coated balloons in coronary interventions, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Dhaka and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseCoronary Artery StenosisDCBEESOptical Coherence TomographySirolimusEverolimusTLF
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.