Clinical Research Directory
Browse clinical research sites, groups, and studies.
Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial
Sponsor: Institute of Cardiovascular Diseases, Vojvodina
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
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.
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