PaneLux PTCA : Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon

Exclusion Criteria

• •1. Pregnant or breast feeding females or females who intend to become pregnant during the time of the study
• •2. Subject with a life expectancy less than 1 year
• •3. Vulnerable subject, protected by law, unable to give his/her consent
• •4. Subject currently enrolled in other medical or drug study and has not reached the primary outcome measures of that study
• •5. Subject unable to be contacted for the clinical follow up at 1, 6 and 12 months
• •6. Subject under chronical oral anti-coagulant treatment (optionnal indication)
• •7. Subject undergoing any urgent invasive or surgical intervention with major bleeding risk, which can not maintain dual anti-platelet therapy (DAPT) for at least 3 weeks
• •8. In stent restenotic lesion
• •9. Target lesion on vessels with nominal diameter \< 2.5 mm
• •10. Target lesion is located in or supplied by an arterial or venous bypass graft
• •11. Chronical Total occlusion (CTO)
• •12. Angioplasty indication for STEMI
• •13. Patient with signs of cardiogenic shock
• •14. Angioplasty antecedent with stent implantation (before 12 months for DES, before 6 months for BMS)
• •15. "Staged procedure" \> 8 days after the initial angioplasty
• •16. Documented left ventricular ejection fraction (LVEF) \</= 30%
• •17. Target lesion requiring before stent implantation a device other than a pre-dilatation balloon (including, but not only restricted to laser, cutting balloon, directional coronary atherectomy, rotational atherectomy etc…)
• •18. Known allergies to acetylsalicylic acid, active agent such Paclitaxel, Expicients like BHTC (Butiriltri-n-hexyl citrate), CoCr, Silicon Carbide.