About this trial
The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).
Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:
* Study group: reduced stent PCI strategy (DCB-based) * Control group: conventional PCI strategy (DES-based).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Life expectancy <1 year due 1 to non-cardiac disease.
Inability to provide informed consent.
Cardiogenic shock.
Left ventricular ejection fraction <15%.
Trial design
Parallel
Treatments tested in this trial
Primary PCI
DeviceCoronary percutaneous revascularization
Treatment groups
Trial outcomes
Primary outcomes
Target lesion failure (TLF)
Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
Secondary outcomes
Incidence of all-cause death
Physicians Assessment
Incidence of myocardial infarction
Physicians Assessment
Incidence of cardiovascular death
Physicians Assessment
Incidence of target lesion revascularization
Physicians Assessment
Sponsors and contacts
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Hospital Universitario La Fe
Lead sponsor
ERA4Health
Collaborator