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Clinical Trials/NCT06353594
NCT06353594
Recruiting
Not Applicable

Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)

Jorge Sanz Sanchez15 sites in 1 country1,272 target enrollmentMarch 11, 2024
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ConditionsST Elevation Myocardial Infarction

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ST Elevation Myocardial Infarction
Sponsor
Jorge Sanz Sanchez
Enrollment
1272
Locations
15
Primary Endpoint
Target lesion failure (TLF)
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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).
Registry
clinicaltrials.gov
Start Date
March 11, 2024
End Date
September 2035
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jorge Sanz Sanchez
Responsible Party
Sponsor Investigator
Principal Investigator

Jorge Sanz Sanchez

Interventional cardiologist

Hospital Universitario La Fe

Eligibility Criteria

Inclusion Criteria

  • •Patients presenting with STEMI and indication to undergo pPCI.

Exclusion Criteria

  • •Life expectancy \<1 year due 1 to non-cardiac disease.
  • •Inability to provide informed consent.
  • •Cardiogenic shock.
  • •Left ventricular ejection fraction \<15%.
  • •Left main disease.
  • •Stent thrombosis
  • •Patients with prior bypass graft lesions requiring PCI (culprit or non culprit lesions).
  • •Patients with chronic total occlusions.
  • •Untreatable coronary disease.
  • •Non-identified culprit lesion.

Outcomes

Primary Outcomes

Target lesion failure (TLF)

Time Frame: 12 months

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

Secondary Outcomes

  • Incidence of bleeding(10 years)
  • Incidence of myocardial infarction(10 years)
  • Incidence of target lesion revascularization(10 years)
  • Incidence of stent thrombosis(10 years)
  • Incidence of acute vessel closure(10 years)
  • Incidence of cardiovascular death(10 years)
  • Incidence of all-cause death(10 years)
  • Incidence of stroke(10 years)
  • Incidence of acute kidney injury(10 years)

Study Sites (15)

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