BIOLUX P-III SPAIN All-Comers Registry

Exclusion Criteria

• •Life expectancy ≤ 1 year
• •Subject is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.
• •Subject is pregnant or planning to become pregnant during the course of the study.
• •Rutherford class \<4
• •Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
• •Intraprocedural decision not to proceed with the Passeo18 Lux DCB for any reason not related to the device (for instance blood flow limiting dissection after predilatation).