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

A Prospective, Randomized, Multicenter, International, Open-Label Clinical Trial Comparing Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Acute ST-Elevation Myocardial Infarction.

This study is testing whether a special balloon or a type of stent works better for treating heart attacks in patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 598 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Cardiovascular Diseases, Vojvodina (Academic / other)
• Locations: 5 sites (Banja Luka and 4 other locations)
• Trial ID: NCT06746233 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old who meet the criteria for STEMI and can undergo primary PCI within 12 hours of symptom onset.

Not a fit: Patients with severe heart failure or those who have had previous heart interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment options for patients experiencing STEMI.

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

Eligibility criteria

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 this trial is running

Banja Luka and 4 other locations

• University Clinical Centre of the Republic of Srpska — Banja Luka, Bosnia and Herzegovina (Recruiting)
• University Clinical Centre of Nis — Niš, Serbia, Serbia (Not_yet_recruiting)
• University Clinical Center of Serbia — Belgrade, Serbia (Recruiting)
• Institute of Cardiovascular Diseases of Vojvodina — Kamenitz, Serbia (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

Conditions ST Elevation Myocardial Infarction; STEMI; DES; DCB