COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.

Exclusion Criteria

• •1. Subjects with ages 18 or below at the time of the procedure.
• •2. Female subjects who may be pregnant or breast-feeding at the time of the procedure.
• •3. Previous PCI of the left main bifurcation.
• •4. Chronic total occlusion of the LAD or LCx.
• •5. Trifurcating left main requiring treatment of the 3 branches.
• •6. LAD and LCx reference sizes are out of the sizing ranges of the used DES/DCB families.
• •7. In-stent restenosis as target lesion.
• •8. Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system.
• •9. ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease.
• •10. Cardiogenic shock.
• •11. Left ventricular ejection fraction below 35%.
• •12. Decision to use mechanical circulatory support for protected PCI.
• •13. Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation).
• •14. Associated significant valvular disease.
• •15. Renal insufficiency with glomerular filtration rate (GFR) \< 20.
• •16. Life expectancy less than one year.