New balloon aims to clear calcified leg arteries safely

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years and ≤ 85 years. * Clinical diagnosis of lower extremity atherosclerotic arterial disease, with a Rutherford Classification of Category 2-5. * The patient has provided written informed consent. * Life expectancy \> 1 year. * Confirmed by clinical and CTA examination: de novo or restenotic lesions after PTA in the femoropopliteal or infrapopliteal arteries, with no stent implantation within 2 cm of the target lesion. Stenosis ≥70% or chronic total occlusion (CTO). * Lesion confirmed by CTA and color Doppler to have moderate to severe calcification (PACSS Grade 3-4). Lesion can be single or tandem, with a total length ≤150 mm. Reference vessel diameter near the target lesion ≥2 mm. * Allowable location of the target lesion: ≥1 cm distal to the common femoral artery bifurcation, and up to 10 cm above the ankle. * If the lesion is below-the-knee (BTK), the inflow vessels must have no non-target lesions, or any non-target lesions must be successfully treated with the current device without vascular complications. * No serious vascular complications such as flow-limiting dissection occur after pre-dilation of the target lesion. * Presence of at least one reconstructible infrapopliteal runoff vessel patent to the ankle. Exclusion Criteria: * Allergy to contrast media. * Coagulopathy; severe hepatic insufficiency (ALT or AST \> 3 times the upper limit of normal). * Cardiac insufficiency (New York Heart Association Class III-IV). * Life expectancy \< 1 year. * Acute cardiovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months; active gastrointestinal bleeding affecting the use of anticoagulant/antiplatelet therapy. * Previous stent implantation or bypass surgery in the target vessel. * Acute/subacute limb ischemia or thrombotic lesions. * Contraindications to anticoagulation or antiplatelet therapy. * Failure to cross the lesion with a guidewire during the procedure; anticipation that the IVUS catheter or DKutting balloon will be unable to cross the lesion after pre-dilation. * Intraoperative occurrence of severe complications requiring conversion to other treatment methods (e.g., bypass surgery). * Pregnant or lactating women. * Active infection at the intended treatment site; foot wounds reaching WIfI Stage 3, or ankle/foot ulcers primarily of non-ischemic etiology. * Patient withdrawal of informed consent. * Planned amputation. * Planned use of adjunctive therapy devices (e.g., atherectomy, laser). * Participation in another interventional drug/device clinical study for lower limb arteries where the primary endpoint has not been reached, or planned participation in such a study. * Patient is bedridden or unable to walk. * Presence of an aneurysm in the ipsilateral limb vasculature.