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

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis

Inclusion Criteria:18-80 year-old male & non-pregnant femalePatients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery.Rutherford clinical category-Becker class: 2 to 5Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study.Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplastyReference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm; Total length of osculation lesion is less than 100mmOnly 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 clinical angiographic success as visually assessed by the physician. The number non-target lesions are limited to maximum 3.Exclusion Criteria:Acute or sub-acute thrombosis exist in target lesionSevere calcified lesion (PACSS Grading 4)Guidewire cannot cross target lesionAmputation planned within 30 daysIn-stent restenosisFlow-limiting dissection (NHLBI grading: D-F) occurred in target lesion by pre-dilationNo 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 Antegrade Dissection Re-entry (ADR) technique.Patient who cannot accept anticoagulant or antiplatelet therapyAware of patient allergic to heparin, contrast, aspirin and clopidogrel, anestheticsPatients who have not completed clinical trials of other drugs or devicesPatients with poor compliance and unable to complete the study, which is identified by investigator.