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NCT Number: NCT06746233

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

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.

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Key information

Conditions

ST Elevation Myocardial Infarction (STEMI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Centre of the Republic of Srpska, Banja Luka, Bosnia and Herzegovina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug (paclitaxel) coated balloon (DCB)

Device

In the experimental arm, a paclitaxel-coated balloon (DCB) delivering 3.0-3.5 µg/mm² will be used in STEMI patients after successful lesion preparation (defined as residual stenosis ≤30%, TIMI flow grade 2-3, and absence of flow-limiting dissection). If the result after DCB treatment is unsatisfactory, bailout implantation of a drug-eluting stent (DES) will be performed at the operator's discretion.

Second-generation Drug Eluting Stent (DES)

Device

In the control arm, patients randomized to the DES treatment group will undergo implantation of a second-generation drug-eluting stent (DES) using standard techniques, according to current practice guidelines

Primary outcomes

  1. DoCE (Device-oriented composite endpoint)

    Time frame: 1 year and 2 years

    DoCE: A composite endpoint consisting of cardiac mortality, non-fatal target vessel myocardial infarction (NF-TVMI), and target lesion revascularization (TLR).

Secondary outcomes

  1. Individual components of the primary endpoint (DoCE)

    Time frame: 1 year and 2 years

    Individual components of the primary endpoint (DoCE):

    • Cardiac mortality
    • Non-fatal target vessel myocardial infarction (NF-TVMI)
    • Target lesion revascularization (TLR)

  2. Patient-oriented composite endpoint (PoCE)

    Time frame: 1 year and 2 years

    PoCE: Defined as a composite of all-cause death, any stroke, any myocardial infarction (MI), and any clinically or physiologically indicated revascularization.

  3. Target vessel revascularization (TVR)

    Time frame: 1 year and 2 years

  4. Target vessel failure (TVF)

    Time frame: 1 year and 2 years

    Target Vessel Failure (TVF): Defined as a composite of cardiac death, target vessel myocardial infarction (MI), and clinically or physiologically indicated target vessel revascularization (TVR).

  5. BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications.

    Time frame: 1 year and 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Branislav Crnomarković, MD

CONTACT

[email protected]

+381642636495

Mila Kovačević, MD, PhD

CONTACT

[email protected]

+381601594444

Sponsors and collaborators

Lead sponsor

Institute of Cardiovascular Diseases, Vojvodina

Other

Registry information

Official study title

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.

Acronym: BOOST-AMI

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 24, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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