Comparing drug-coated balloons and drug-eluting stents for heart attack treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of drug-coated balloons (DCB) versus the standard drug-eluting stents (DES) in patients experiencing ST-elevation myocardial infarction (STEMI). After confirming that patients meet specific angiographic criteria, they will be randomly assigned to receive either a Paclitaxel-coated balloon or a second or third-generation DES during percutaneous coronary intervention (PCI). The goal is to determine which treatment leads to better outcomes for patients suffering from this acute heart condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>18 years with a life expectancy of \>1 year;
* Patients fulfilling criteria for STEMI (\>20 min of chest-pain; At least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction confirmed by ECG or echocardiography; Reperfusion is expected to be feasible within 12 h after onset of symptoms)
* Infarct related artery eligible for primary PCI (De novo lesion in a native coronary artery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severe calcification; Residual diameter stenosis of ≤30% (by visual assessment) after lesion preparation after lesion preparation; Absence of coronary dissection type ≥C.

Exclusion Criteria:

* Killip class\>II on admission
* Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb/IIIa inhibitor
* Previous myocardial infarction
* Previous PCI in the territory of the infarct-related artery (IRA)
* Previous CABG
* 3-vessel disease requiring revascularization
* Left-main disease
* Extremely angulated or severely calcified vessels
* History of ischemic stroke within the past 6 months or hemorrhagic stroke
* Planned CABG for a non-culprit vessel
* Participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study

Where it's running

• University Clinical Centre of the Republic of Srpska
  Banja Luka, Bosnia and Herzegovina Recruiting
• University Clinical Center of Serbia
  Belgrade, Serbia Recruiting
• Institute of Cardiovascular Diseases of Vojvodina
  Kamenitz, Serbia Recruiting
• University Clinical Centre of Nis
  Niš, Serbia, Serbia Not yet recruiting
• University Clinical Center of Kragujevac
  Kragujevac, Serbia Not yet recruiting

Study contacts

• Principal investigator: Mila Kovačević, MD, PhD — Institute of Cardiovascular Diseases of Vojvodina
• Study coordinator: Mila Kovačević, MD, PhD
• Email: milakov979@gmail.com
• Phone: +381601594444

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Reducing slow-flow and no-reflow during STEMI with a high-dose intracoronary adenosine protocol

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  Recruiting at 2 sites Punjab Institute of Cardology · Lahore, Punjab Province and 1 other locations · NCT07898696

• Drug-coated balloons vs drug-eluting stents for immediate slow-flow/no-reflow in STEMI with high thrombus

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• CHIP in STEMI: Does clonal hematopoiesis influence infarct severity

  This study tests whether clonal hematopoiesis (CHIP) affects infarct size and microvascular injury in people having a heart attack treated with PCI.

  Recruiting Medical University Innsbruck · Innsbruck, Tyrol · NCT07615023

• Digitally supported personalized nutrition to improve heart pumping after ST‑elevation heart attack

  This program will test whether a three-month personalized diet plan with digital support can improve heart pumping (left ventricular ejection fraction) in adults who recently had a STEMI.

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• Giving heparin before arrival for people with STEMI who will have primary PCI.

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  Recruiting Renmin Hospital of Wuhan University · Wuhan, Hubei · NCT07361783

• Investigating microplastics in patients with heart attacks

  This study is testing whether tiny plastic particles found in the body affect heart health in patients who have had a heart attack and are getting urgent treatment.

  Recruiting at 2 sites Azienda Ospedaliera "Sant'Andrea" · Roma, Rome and 9 other locations · NCT06965023

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.