Clinical Research Directory

Inclusion Criteria: * 1\. Age ≥18 years old and ≤75 years old * 2\. Rutherford clinical category classification：3,4 or 5 * 3\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent. * 4\. Reference vessel diameter is between 2 mm and 4 mm * 5\. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments. Exclusion Criteria: * 1\. Plasma creatinine clearance rate \<30 mL/min * 2\. Acute vessel occlusion or acute thrombosis in target lesion * 3\. Planned amputation on the target limb * 4\. Subjects confined to bed that are completely non-ambulatory. * 5\. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment. * 6\. Life expectancy \< 5 year. * 7\. Cumulative length of 100% occluded target lesion(s)\>150 mm * 8\. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm * 9\. History of stroke within 90 days prior to enrollment * 10\. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy * 11\. Uncorrectable bleeding diathesis * 12\. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery * 13\. Pregnant or breastfeeding female subjects * 14\. Ability to cross a guidewire through target lesion * 15\. Patients who have participated in clinical trials of other medical devices or drugs during the same period