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Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06746233•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (4)

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

Key Dates

Start Date

December 25, 2024

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2028

Last Updated

April 1, 2025

Enrollment

598

ESTIMATED participants

Conditions

ST Elevation Myocardial Infarction (STEMI)

Interventions

Drug (paclitaxel) coated balloon (DCB)

DEVICE

Second-generation Drug Eluting Stent (DES)

DEVICE

Contacts

Mila Kovačević, MD, PhD

CONTACT

+381601594444 milakov979@gmail.com

Branislav Crnomarković, MD

CONTACT

+381642636495 branislavc.89@gmail.com

ST Elevation Myocardial Infarction Hemodynamic OutComes: Role of Non-Invasive Cardiac System (SHOCk-NICaS) Study

NCT04586764

ST Elevation Myocardial Infarction (STEMI) Patients

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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