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

Study Overview
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Brief Summary
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Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.

Detailed Description
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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.

Official Title
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The Safety and Efficacy of Drug Eluting Peripheral Vascular Stent System for the Treatment of Superficial Femoral Artery Stenosis and /or Occlusion: a Multi-center Stratified Randomized Single- Blind Controlled Trial

Conditions
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Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion

Intervention / Treatment
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* Device: Drug eluting peripheral vascular stent system
* Device: Nitinol Stent System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>subjects using the drug eluting peripheral vascular stent system | Device: Drug eluting peripheral vascular stent system<br>* Drug eluting peripheral vascular stent system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）<br>|
| Active Comparator: Group B<br>subjects using the Nitinol Stent System (Cordis Corporation) | Device: Nitinol Stent System<br>* Nitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）<br>* Other names: Cordis Corporation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary patency rate at 12 months after operation | the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary patency rate at 6 months after operation | the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 6 months postoperatively | 6 months | 
| target lesion revascularization rate | 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 | Preoperative，up to 1 month，6 months，12 months | 
| Stent fracture rate | using the Dual Fluoroscopic Imaging | 6 months、12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral arterial disease, primary patency, Drug eluting peripheral vascular stent system