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

NCT06746233 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2026-03-30

No results posted yet for this 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.

Conditions

  • ST Elevation Myocardial Infarction (STEMI)

Interventions

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.

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

Sponsors & Collaborators

  • Institute of Cardiovascular Diseases, Vojvodina

    lead OTHER

Principal Investigators

  • Mila Kovačević, MD, PhD · Institute of Cardiovascular Diseases of Vojvodina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-25
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Bosnia and Herzegovina
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06746233 on ClinicalTrials.gov