Clinical trial NCT06746233: Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial
Official title: Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST Elevation Myocardial Infarction (STEMI)
Keywords: STEMI
DES
DCB
Lead sponsor: Institute of Cardiovascular Diseases, Vojvodina
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study

Primary outcomes:
measure: DoCE (Device-oriented composite endpoint)
timeFrame: 1 year and 2 years
Secondary outcomes:
measure: Individual components of the primary endpoint (DoCE)
timeFrame: 1 year and 2 years
measure: Patient-oriented composite endpoint (PoCE)
timeFrame: 1 year and 2 years
measure: Target vessel revascularization (TVR)
timeFrame: 1 year and 2 years
measure: Target vessel failure (TVF)
timeFrame: 1 year and 2 years
measure: BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications.
timeFrame: 1 year and 2 years
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Kragujevac
country: Serbia
facility: University Clinical Center of Kragujevac
city: Niš
country: Serbia
facility: University Clinical Centre of Nis
city: Sremska Kamenica
country: Serbia
facility: Institute of Cardiovascular Diseases of Vojvodina
Study officials:
affiliation: Institute of Cardiovascular Diseases of Vojvodina
name: Mila Kovačević, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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