OPTIMIZE BTK: Orbitale Gefäßpräparierung zur Maximierung der Wirksamkeit eines medikamentenbeschichteten Ballons (drug coated balloon, DCB) bei kalzifizierten Läsionen unterhalb des Knies (below the knee, BTK)

Device: Peripheral Orbital Atherectomy System;Device: 014 Drug Coated Balloon

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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