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RECRUITING
NCT06746233
NA

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

Sponsor: Institute of Cardiovascular Diseases, Vojvodina

View on ClinicalTrials.gov

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.

Official 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

598

Start Date

2024-12-25

Completion Date

2028-12

Last Updated

2026-03-30

Healthy Volunteers

No

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

Locations (5)

University Clinical Centre of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina

University Clinical Centre of Nis

Niš, Serbia, Serbia

University Clinical Center of Serbia

Belgrade, Serbia

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, Serbia

University Clinical Center of Kragujevac

Kragujevac, Serbia