Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial (BOOST-AMI)

March 25, 2026 updated by: Mila Kovacevic, Institute of Cardiovascular Diseases, Vojvodina

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

598

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 21204
        • Recruiting
        • University Clinical Centre of the Republic of Srpska
        • Principal Investigator:
          • Bojan Stanetić, MD, PhD
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia
        • Contact:
        • Principal Investigator:
          • Zlatko Mehmedbegović, MD
      • Kamenitz, Serbia, 21204
        • Recruiting
        • Institute of Cardiovascular Diseases of Vojvodina
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mila Kovačević, MD, PhD
      • Kragujevac, Serbia, 34000
        • Not yet recruiting
        • University Clinical Center of Kragujevac
        • Principal Investigator:
          • Miodrag Srećković, MD, PhD
        • Contact:
    • Serbia
      • Niš, Serbia, Serbia, 18105
        • Not yet recruiting
        • University Clinical Centre of Nis
        • Contact:
        • Principal Investigator:
          • Bojan Maričić, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Second generation of drug eluting stents (DES)
Drug eluting stent (DES)
Device: Second-generation Drug Eluting Stent (DES)
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
Experimental: Drug coated balloon (DCB)
Drug (paclitaxel) coated balloon (DCB) with concentration of 3-3.5 μg Paclitaxel per 1 mm2
Device: Drug (paclitaxel) coated balloon (DCB)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year and 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year and 2 years
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.
1 year and 2 years
Target vessel revascularization (TVR)
Time Frame: 1 year and 2 years
1 year and 2 years
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).
1 year and 2 years
BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications.
Time Frame: 1 year and 2 years
1 year and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiovascular Diseases, Vojvodina

Investigators

  • Principal Investigator: Mila Kovačević, MD, PhD, Institute of Cardiovascular Diseases of Vojvodina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICDVojvodina 1482-1/3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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