Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario La Fe

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Primary PCI

    Device

    Coronary percutaneous revascularization

Treatment groups

1,272 Participants
are divided into 2 treatment groups
Group A: DCB-basedExperimental treatment 1 intervention
Group B: DES-basedNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Target lesion failure (TLF)

Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

Time frame
12 months

Secondary outcomes

1

Incidence of all-cause death

Physicians Assessment

Time frame
10 years
2

Incidence of myocardial infarction

Physicians Assessment

Time frame
10 years
3

Incidence of cardiovascular death

Physicians Assessment

Time frame
10 years
4

Incidence of target lesion revascularization

Physicians Assessment

Time frame
10 years

Other outcomes

Sponsors and contacts

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