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Status:

NOT_YET_RECRUITING

Comparison of HYBRID Versus Two-Stent Strategies in Unprotected True Left MAIN Bifurcation

Lead Sponsor:

Hospital Sultanah Bahiyah

Collaborating Sponsors:

Clinical Research Malaysia

Conditions:

Unprotected Left Main Coronary Artery Disease

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The number of deaths from heart disease is rising globally, particularly in developing countries. This condition involves the narrowing of arteries that supply blood to the heart. The most critical na...

Detailed Description

Percutaneous coronary intervention (PCI) of unprotected distal left main bifurcation (UTLMB) lesions remains technically demanding and is associated with higher risks than interventions in non-left ma...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Floating eligibility criteria
  • De novo unprotected true left main bifurcation (UTLMB) (Medina 1,1,1; 1,0,1; and 0,1,1).
  • Optimal LCx lesion preparation (residual stenosis less than 30% with absence of flow-limiting dissection).
  • The operator feels it might be appropriate to place either a drug-eluting stent (DES) or drug-coated balloon (DCB) to the LCX
  • Clinically stable at the time of randomisation.
  • Able to complete 2-year follow-up.
  • Able to complete dual antiplatelet therapy (DAPT) as per guidelines.
  • Written informed consent (or verbal consent on-table with written consent as soon as possible thereafter).
  • Exclusion Criteria:
  • Protected left main (patent graft to LAD and LCX)
  • Need for anticoagulation
  • LCx reference vessel diameter less than 2.5 mm (\< 2.5 mm)
  • Cardiogenic shock
  • Severe left ventricular (LV) dysfunction making either strategy unsafe
  • Contraindication to antiplatelet therapy or study devices
  • Life expectancy less than 2 years
  • Participation in another trial that may affect results

Exclusion

    Key Trial Info

    Start Date :

    January 1 2026

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 1 2030

    Estimated Enrollment :

    800 Patients enrolled

    Trial Details

    Trial ID

    NCT07159737

    Start Date

    January 1 2026

    End Date

    January 1 2030

    Last Update

    December 30 2025

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