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

Institute of Cardiovascular Diseases, Vojvodina4 sites in 1 country598 target enrollmentDecember 25, 2024

ConditionsST Elevation Myocardial Infarction (STEMI)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ST Elevation Myocardial Infarction (STEMI)
Sponsor: Institute of Cardiovascular Diseases, Vojvodina
Enrollment: 598
Locations: 4
Primary Endpoint: DoCE (Device-oriented composite endpoint)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 25, 2024

End Date

December 2028

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institute of Cardiovascular Diseases, Vojvodina

Responsible Party

Principal Investigator

Mila Kovacevic

Assistant Professor, MD, PhD

University of Novi Sad

Eligibility Criteria

Inclusion Criteria

•Age \>18 years with a life expectancy of \>1 year;
•Patients fulfilling criteria for STEMI (\>20 min of chest-pain; At least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction confirmed by ECG or echocardiography; Reperfusion is expected to be feasible within 12 h after onset of symptoms)
•Infarct related artery eligible for primary PCI (De novo lesion in a native coronary artery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severe calcification; Residual diameter stenosis of ≤30% (by visual assessment) after lesion preparation after lesion preparation; Absence of coronary dissection type ≥C.

Exclusion Criteria

•Killip class\>II on admission
•Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb/IIIa inhibitor
•Previous myocardial infarction
•Previous PCI in the territory of the infarct-related artery (IRA)
•Previous CABG
•3-vessel disease requiring revascularization
•Left-main disease
•Extremely angulated or severely calcified vessels
•History of ischemic stroke within the past 6 months or hemorrhagic stroke
•Planned CABG for a non-culprit vessel

Outcomes

Primary Outcomes

DoCE (Device-oriented composite endpoint)

Time Frame: 1 year and 2 years

DoCE: A composite endpoint consisting of cardiac mortality, non-fatal target vessel myocardial infarction (NF-TVMI), and target lesion revascularization (TLR).

Secondary Outcomes

Target vessel revascularization (TVR)(1 year and 2 years)
Individual components of the primary endpoint (DoCE)(1 year and 2 years)
Patient-oriented composite endpoint (PoCE)(1 year and 2 years)
Target vessel failure (TVF)(1 year and 2 years)
BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications.(1 year and 2 years)