Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

Inclusion Criteria: * Subject's age ≥ 18 years * Rutherford Clinical Category 3 - 5 * Lesions \[except in-stent restenosis (ISR)\] of the distal popliteal (POP segment below the anatomical knee joint), anterior tibial, posterior tibial, tibial peroneal trunk, and peroneal arteries with ≥ 70 % diameter stenosis (DS) by angiography * Presence of clearly visible calcification in two views (both sides of vessel at the same location) evaluated angiographically- \[Computerized tomography (CT) angio images may substitute to confirm distribution of calcium, if available as standard of care\] * Length of calcium ≥ 25 % of total lesion length or ≥ 2 cm total length * Target lesion length up to 20 cm Exclusion Criteria: * Subject or subject's legal representative is not willing to sign an Ethics Committee approved informed consent form or comply with the study protocol requirements * Contraindicated by either device, per Instructions For Use * Presence of inflow lesion (≥ 50 % DS) or inflow not successfully treated (≥ 50% DS and/or unresolved significant angiographic complication) * Compromised outflow distal to the target lesion (≥ 70 % DS) or presence of lesion(s) or occlusion(s) located from 5 cm above the ankle to below the ankle joint space * Subject has more than 2 target vessels requiring treatment * The guide wire cannot be passed across the target lesion(s) and/or guide wire position distal to target lesion(s) outside vessel lumen * Presence of significant (≥ 70 % DS) lesion(s) or occlusion(s) not meeting the study criteria which were not successfully treated during the index procedure (≥ 50 % DS and/or significant angiographic complication) * Subject has planned amputation (including minor) of the index limb or previous major amputation of the contralateral limb * Creatinine \> 2.5 mg/dL, unless on dialysis * Subject has any significant medical condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study * Subject is participating in an investigational drug or device study that has the potential to clinically interfere with the study outcome measures * Subject is pregnant or planning to become pregnant within the study period * Subject has an unresolved severe systemic infection * Subject has an anticipated life span of less than one year * Subjects with known hypersensitivity to paclitaxel or paclitaxel related compounds * Subjects who cannot receive recommended anti-platelet and/or anticoagulant therapy * Pre-dilatation of the target lesion prior to randomization and OA treatment