Eluvia DES for the Patients With Femoropopliteal Artery Lesions.

Study Overview
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Brief Summary
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This study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with Eluvia stent. Each patient was followed up for 2 years. The technical success rate, target lesion patency rate, quality of life improvement, cost of Eluvia stent implantation, and other outcomes will be analysed.

Official Title
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Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions

Conditions
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Vascular Diseases, Stent Complication

Intervention / Treatment
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* Device: Eluvia drug eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rutherford Stage 2-5. At least 90% stenosis or occlusion of the femoropopliteal artery. Eluvia stents are used for target lesions. Agree and sign the informed consent form Exclusion Criteria: Life expectancy is less than 1 year. Those with severe infection and gangrene of the limbs or those with tissue defects beyond the plane of the toes (ie major tissue loss), who may undergo major amputation even if the blood vessels are opened. Patients and their families are reluctant to join the observational study, or have difficulty in communication and are unable to assess the quality of life. Patients with in-stent restenosis of the femoral popliteal artery. Patients with acute arterial thrombosis.
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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Eluvia drug eluting stent|Eluvia drug eluting stent for peripheral arterial disease|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Rutherfor classification | Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months | 24 months | 
| F-TLR | free of target vascular reconstruction | 24 months | 
| limb salvage rate | Proportion of patients without ambutation | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | Percentage of patients with successful endovascular treatment without postoperative complications | 1 month | 
| the patency target lesion | Restenosis was defined as PSVR > 2.4 as determined by vascular ultrasonography | 24 months | 
| mortality rate | the propotion of death | 24 months | 
| the life quality change | Amount by Vas-Qol questionare between perioperation and 24month postoperation | 24 months | 
| the life quality change | Amount by EQ-5D5L questionare between perioperation and 24month postoperation | 24 months | 
| Economics Evaluation | Cumulative hospitalization expenses related to treatment within 24 months | 24 months | 
| Wound Healing Evaluation | If there is an ulcer wound, evaluate the ulcer wound healing at 24 months after surgery and before treatment | 24 months |