Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial

Last updated: March 30, 2025
Sponsor: Institute of Cardiovascular Diseases, Vojvodina
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Heart Defect

Coronary Artery Disease

Treatment

Second-generation Drug Eluting Stent (DES)

Drug (paclitaxel) coated balloon (DCB)

Clinical Study ID

NCT06746233
ICDVojvodina 1482-1/3
  • Ages > 18
  • All Genders

Study Summary

The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction (STEMI).

Randomization will be performed after successful culprit-lesion preparation and confirmation that all angiographic entry criteria are met. Patients will be randomly assigned in a 1:1 fashion to receive either treatment with a Paclitaxel-coated balloon alone or second or third-generation DES.

Eligibility Criteria

Inclusion

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 mmST-elevation in at least two contiguous leads, a new left bundle branch block or atrue 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 coronaryartery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severecalcification; Residual diameter stenosis of ≤30% (by visual assessment) afterlesion preparation after lesion preparation; Absence of coronary dissection type ≥C.

Exclusion

Exclusion Criteria:

  • Killip class>II on admission

  • Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb/IIIainhibitor

  • 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 primaryendpoint or could interfere with the endpoints of this study

Study Design

Total Participants: 598
Treatment Group(s): 2
Primary Treatment: Second-generation Drug Eluting Stent (DES)
Phase:
Study Start date:
December 25, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • University Clinical Center of Serbia

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • University Clinical Center of Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • University Clinical Centre of Nis

    Nis, 18105
    Serbia

    Site Not Available

  • University Clinical Centre of Nis

    Niš, 18105
    Serbia

    Site Not Available

  • Institute of Cardiovascular Diseases of Vojvodina

    Sremska Kamenica, 21204
    Serbia

    Active - Recruiting

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