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

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

The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.

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