AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China

Inclusion Criteria: * Age between 18 and 85 years * Patients with peripheral artery disease (PAD), with Rutherford classification between 4 and 6 * an occlusion or a minimum grade of stenosis Primary over 70% in the below popliteal artery * The expected survival time is more than 1 year * signed Patient informed consent form Exclusion Criteria: * Serum creatinine clearance rate less than 30ml/min in patients * patients with acute thrombosis requiring lysis or thrombectomy * patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks * patient requiring intervention in both lower limbs at the same time * In-stent restenosis in the blow-knee popliteal artery * target lesion can't be cross by the guide wire * the stenosis rate of proximal outflow more than 30% with or without intervention * the length of the stenosis or occlusion in proximal outflow(including the Iliac artery, the superficial femoral artery, the Popliteal artery) more than 150mm before intervention * stenosis or occlusion of distal outflow for below-the-ankle artery. * expected major amputations at the index limb before intervention * known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc. * patients participating in another clinical trials with interfere with this trial in the same time * pregnancy and lactating woman * untreatable bleeding diatheses