Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion

This is a prospective, multicenter, randomized study designed to enroll 138 patients with superficial femoral artery stenosis and /or occlusion who will be randomized 1:1 to be treated with the Drug eluting peripheral vascular stent system versus the commercially available Nitinol Stent System (Cordis Corporation). Patients will receive Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging at 6th month and 12th month post procedure. Clinical visits are scheduled at 0\~30 days, 6 months, 12 months, and telephone visits are scheduled at 1 month, 3months, and 9 months. Furthermore, CDU will also be performed at baseline in all participants of the study.

• Drug eluting peripheral vascular stent system (Device): Drug eluting peripheral vascular stent system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
• Nitinol Stent System (Device), also known as Cordis Corporation: Nitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）

Primary outcomes

• primary patency rate at 12 months after operation [12 months]: the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively

Secondary outcomes

• primary patency rate at 6 months after operation [6 months]: the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 6 months postoperatively
• target lesion revascularization rate [Preoperative，up to 1 month，6 months，12 months]: subject found that the presence of restenosis in the target lesion in follow-up , and need to re-intervention or bypass graft according to the clinical symptoms
• Stent fracture rate [6 months、12 months]: using the Dual Fluoroscopic Imaging

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria in Preoperative:

* Aged from 18 to 85 years old, male or female
* Subject's target lesions were stenosis and/or occlusion
* Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent

Exclusion Criteria in Preoperative:

* In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration
* Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration
* Subject with coagulation abnormalities should not be performed

• Chen Zhong, Principal investigator, Beijing Anzhen Hospital
• Guo Wei, Principal investigator, Chinese PLA General Hospital