Clinical Research Directory

Inclusion Criteria: * ≥18 years of age. * Rutherford class 4-5. * Estimated life expectancy \>1 year, per investigator's judgment. * Significant atherosclerotic lesions (≥50% stenosis or chronic total occlusion) in the femoropopliteal segment, including in-stent restenosis. * Signed informed consent. * Willingness to comply with follow-up visits. * ≥1 patent infragenicular artery (\<50% stenosis) at the end of the procedure. * Target vessel diameter ≤8 mm. Exclusion Criteria: * Pregnant or planning pregnancy during the study. * Participation in another drug/device trial. * Inability to cross the target lesion with a guidewire. Successful crossing is defined as advancement of the guidewire tip distal to the target lesion without vessel perforation or flow-limiting dissection. * Inadequate treatment of proximal lesion (\>30% residual stenosis). * Severe calcification of the target vessel \[group 4 of Fanelli classification17 defined as circumferential calcification (270º-360º)\], evidenced before contrast injection or digital subtraction angiography. * Thrombus in the target vessel. * Anastomotic stenosis of a bypass. * Use of atherectomy, thrombectomy, laser, or similar devices. * Prior or planned above-the-ankle amputation of the target limb. * Coagulopathy, hypercoagulable state, bleeding diathesis, platelets \<80 000/µL or \>700 000/µL, or other blood disorder. * Gastrointestinal bleeding requiring transfusion within 3 months. * Contraindication to antiplatelet/anticoagulant/thrombolytic therapy. * Acute coronary syndrome within 30 days. * Stroke or TIA within 90 days. * Hypersensitivity/contraindication to nitinol. * Comorbidities precluding treatment or follow-up (per investigator). * Hypersensitivity/allergy to contrast not manageable medically. * Hypersensitivity/allergy to heparin, aspirin, paclitaxel, clopidogrel, or other antiplatelet/anticoagulant agents. * Contraindication to dual antiplatelet therapy.