Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter

Exclusion Criteria

• •1\. Patient with arteritis;
• •2\. Any acute thrombosis of target vessels requires thrombolysis or thrombectomy, or accepted local or systemic thrombolysis within 48 hours；
• •3\. Any cerebrovascular accidents within 3 months；
• •4\. Any unstable coronary heart disease or myocardial infarction within 3 months；
• •5\. Any important organ failure；
• •6\. Any known hypersensitivity to heparin, aspirin, clopidogrel, paclitaxel, paclitaxel compounds and contrast agents;
• •7\. Cannot accept antiplatelet and/or anticoagulation therapy；
• •8\. Patients with hemorrhagic physical diseases；
• •9\. Alanine transaminase (ALT) or Aspartate transaminase (AST) were five times higher than the normal upper limit；
• •10\. Serum creatinine \> 2mg/dl (177umol/L)；
• •11\. Pregnant or lactating woman；
• •12\. In the absence of intervention, the three lumens of tibialis anterior, tibialis posterior and peroneal artery stenosis or occlusion degree were all \>50%；
• •13\. iliac artery stenosis \>50%, or lumen stenosis \>50% after treatment (Limited to non-drug-eluting balloon or stent treatment only)；
• •14\. The guide wire cannot pass through target lesions (Passing through target lesions refers to the head of the guidewire arrive beyond the lesion in the absence of interlayer or perforation)；
• •15\. Severe calcification at target lesions and should not be treated with balloon dilatation therapy;
• •16\. Pre-dilation or anticipated severe vascular dissections after dilation;
• •17\. Residual stricture of \>50% or severe current-limiting dissection after pre-dilation is not suitable for simple balloon dilatation catheter treatment;
• •18\. The total length of target lesions is \>200mm, or the reference diameter of the target vessel was \>7mm or \<3mm;
• •19\. Life expectancy is less than one year;
• •20\. Participated in clinical trials of other drugs or instruments at the same time;
• •21\. Other conditions not suitable for inclusion judged by researchers.