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

• Sirolimus-eluting balloon catheter (Device), also known as Sirolimus coated balloon catheter: Sirolimus-eluting balloon catheter designed and produced by Acotec
• Paclitaxel-eluting balloon catheter (Device), also known as Paclitaxel coated balloon catheter: Paclitaxel-eluting balloon catheter (trade name:DHALIA)

Primary outcomes

• The primary patency rate of target lesion at 12 months post-procedure [12 months post-procedure]: Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)

Secondary outcomes

• Rate of device success [immediate post-procedure]: Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
• Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure [12 months post-procedure]: Defined as any reintervention at the target lesion due to symptoms or the following index: drop of ABI >20% or ABI >0.15 compared to the post-procedure ABI during 12 months post-procedure
• The change of Rutherford class from baseline [12 months post-procedure]: Defined as change in target limb Rutherford class from baseline to 12 months
• The change of ankle-brachial index (ABI) from baseline [12 months post-procedure]: Defined as change of target limb ABI from baseline to 12 months
• Rate of composite safety endpoint [30 days post-procedure]: Defined a composite rate of device-related or procedure-related death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) or target lesion thrombotic events through 30 days post- procedure

Sex: All, ages: 18 Years to 80 Years

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.

• Guo Wei, MD, Principal investigator, Chinese PLA General Hospital