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ExploreTrial

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EXPLORE COMPLETED!!!!

304 patients enrolled!

Inclusion Criteria

Inclusion Criteria

  • STEMI:typical chest pain, ST-elevation according to the guidelines 
  • Successful PPCI
  • CTO:
    • Located in a non infarct related artery.
      • 100% luminal narrowing or without anterograde flow or antegrade or retrograde filling through collaterals.
        • amenable to PCI treatment
          • reference diameter of ≥ 2.5 mm

 

 

 

Exclusion Criteria

 

  • Age ≥ 80 years
  • Atrial fibrillation
  • Renal insufficiency (creatinin ≥ 265 µmol/L or ≥ 3.5 mg/L)
  • More than 48 hrs of pre-shock or shock after primary PCI
  • Cardiac events between primary PCI and randomization
  • Significant left main stenosis
  • Indication for CABG
  • Severe valvular heart disease
  • Indication for ICD
  • Contra-indications for MRI
  • Baseline MRI not suitable for endpoint assessment
  • Serious known concomitant disease
  • Circumstances that prevent follow-up
  • Previous participation in this trial
  • Current participation in another trial

 

Primary Endpoints

 

Measured by cardiovascular magnetic resonance imaging at 4 months:

 

  • Left ventricular ejection fraction
  • Left ventricular end-diastolic volume

 

Secondary Endpoints

 

Safety Endpoints

 

  • Major Adverse Cardiac Events, defined as cardiac death, myocardial infarction or CABG at 30 days, 4 months, and 1, 2, 3, 4, and 5 years.
  • Stent thrombosis, classified as definite, probable or possible

 

Other Secondary Endpoints

 

Measured by cardiac magnetic resonance imaging at 4 months:

 

  • Left ventricular end systolic volume
  • Left ventricular segmental wall thickening
  • Left ventricular massÍnfarct size 
  • Infarct size
  • N-terminal-proBrain Natriuretic Peptide (at 4 months and 1 year, relative to baseline)
  • Heart rate adjusted QT duration measured by resting electrocardiogrpahy (at 4 months and 1 year, relative to baseline)
  • Quantitative Coronary Angiography of the treated chronic total occlusions: in-stent and in-segment late luminal loss at 12 months 
  • In-stent and in-segment minimal luminal diameter
  • In-stent and in-segment binary restenosis rate
  • Repeat hospitalization for cardiac causes at 30 days, 4 months, and 1, 2, 3, 4, and 5 years
  • Presence of clinically overt heart failure at 30 days, 4 months, and 1, 2, 3, 4, and 5 years
  • Implantation of implantable cardioverter-defibrillator devices
  • Functional Class: NYHA classification at 30 days, 4 months, and 1, 2, 3, 4, and 5 years