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CORENCT07892976

The CORE Platform Trial

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalisation (the primary outcomes defined for the first randomised comparison in the CORE Platform Trial)
Timeframe: 12 months after randomisation

Secondary (3)

Angina symptoms (an example of a secondary outcome used in the first randomised comparison in the CORE Platform Trial).
Health-related quality of life (an example of a secondary outcome used in the first randomised comparison in the CORE Platform Trial).
Hospital free days (an example of a secondary outcome used in the first randomised comparison in the CORE Platform Trial).

Arms and interventions

Minimally invasive direct coronary artery bypass (MIDCAB) procedureExperimental

The MIDCAB procedure aims to provide a less invasive approach to revascularisation than CABG, while providing greater treatment flexibility than PCI alone. MIDCAB involves grafting the left anterior descending artery (LAD) through a small anterior thoracotomy incision, eliminating the need for extracorporeal circulation (heart-lung machine) and sternotomy. This approach ensures vital revascularisation with reduced surgical trauma. Hybrid coronary revascularisation (HCR) combines the advantages of invasive cardiology, including stents, and cardiac surgery. This procedure involves minimally invasive grafting of the left internal mammary artery (LIMA) to the LAD, combined with PCI of all significant non-LAD stenoses.

Conventional coronary artery bypass grafting (CABG) procedureActive comparator

CABG is a common surgical procedure with a full sternotomy and bypass grafting. CABG is considered the gold standard for treating complex multivessel coronary artery disease.

Procedures: MIDCAB procedure, CABG procedure

Sites

3 sites in 3 countries

Belgium 1, Denmark 1, Netherlands 1