DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis

Inclusion Criteria:

• 18-80 year-old male & non-pregnant female
• Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis orosculation in femoropopliteal artery.
• Rutherford clinical category-Becker class: 2 to 5
• Patients understand the purpose of the study, will voluntarily participate in thestudy and sign informed consent. Patients are willing to undergo clinical follow-up asrequired by this study.
• Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%,appropriate for treatment with balloon angioplasty
• Reference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm;Total length of osculation lesion is less than 100mm
• Only one target lesion needs to be Treated. Treatment of non-target lesion, if any,must be completed prior to treatment of target lesion and must be deemed a clinicalangiographic success as visually assessed by the physician. The number non-targetlesions are limited to maximum 3.

Exclusion Criteria:

• Acute or sub-acute thrombosis exist in target lesion
• Severe calcified lesion (PACSS Grading 4)
• Guidewire cannot cross target lesion
• Amputation planned within 30 days
• In-stent restenosis
• Flow-limiting dissection (NHLBI grading: D-F) occurred in target lesion bypre-dilation
• No other lumen-reduction devices (such as: cutting balloon, dual-wire balloon, Hawk,ELCA etc.) are treated before or after test/control group treatment.
• Before test/control group treatment, target lesion was expanded by AntegradeDissection Re-entry (ADR) technique.
• Patient who cannot accept anticoagulant or antiplatelet therapy
• Aware of patient allergic to heparin, contrast, aspirin and clopidogrel, anesthetics
• Patients who have not completed clinical trials of other drugs or devices
• Patients with poor compliance and unable to complete the study, which is identified byinvestigator.