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

NARecruitingINTERVENTIONAL
Enrollment

598

Participants

Timeline

Start Date

December 25, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
ST Elevation Myocardial Infarction (STEMI)
Interventions
DEVICE

Drug (paclitaxel) coated balloon (DCB)

In the experimental arm, a drug-coated balloon (DCB) with a concentration of 3 μg of Paclitaxel per 1 mm² will be used in patients with STEMI following 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, a bailout drug-eluting stent (DES) will be implanted.

DEVICE

Second-generation Drug Eluting Stent (DES)

If the patient is randomized to the DES treatment arm, a second-generation drug-eluting stent (DES) will be implanted using standard techniques.

Trial Locations (4)

11000

RECRUITING

University Clinical Center of Serbia, Belgrade

18105

NOT_YET_RECRUITING

University Clinical Centre of Nis, Niš

21204

RECRUITING

Institute of Cardiovascular Diseases of Vojvodina, Kamenitz

34000

NOT_YET_RECRUITING

University Clinical Center of Kragujevac, Kragujevac

All Listed Sponsors
lead

Institute of Cardiovascular Diseases, Vojvodina

OTHER