Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Drug eluting balloon catheter, Peripheral Artery Disease Read More

Inclusion Criteria:

• Age ≥18 years old and ≤80 years old
• Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
• SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.
• The length of target lesion less than 20 cm
• Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed

Exclusion Criteria:

• The plasma creatinine level is higher than 150 umol/L
• Thrombolysis or thrombectomy is required
• There are more than 2 lesion need to treat in the target vessel.
• The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
• The target lesion had residual stenosis>30% or flow-limit dissection after pre-dilatation.
• The patient had outflow less than 1 vessel
• The lesion located in a stent.
• Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated.
• Women who are pregnant or breast-feeding.
• The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
• Patient has life expectancy of less than 12 months.
• The investigator think the patient is not suitable for participation in the clinical trial.