NCT06746233

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

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 598 (estimated)
• Sponsor: Institute of Cardiovascular Diseases, Vojvodina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-12-25
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2024-12-24
• Last updated: 2026-03-30

Locations

5 sites across 2 countries: Bosnia and Herzegovina, Serbia