AcoArt Ⅰ / SFA China

Study Overview
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Brief Summary
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The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.

Official Title
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Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: drug eluting balloon catheter (trade name: Orchid)
* Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 80 years Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5 an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery Total length of treat lesion(s)is less or equal to 40cm signed Patient informed consent form Exclusion Criteria: plasma Cr level greater than 150 umol/L in patients patients with acute thrombosis requiring lysis or thrombectomy patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks patient requiring intervention in both lower limbs at the same time target lesion can't be cross by the guide wire distal outflow through less than one lower leg vessel known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc. patients participating in another clinical trials with interfere with this trial in the past 3 months pregnancy and lactating woman untreatable bleeding diatheses other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 2 years) patients unable or unwilling to participate this trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: drug eluting balloon catheter<br>use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery | Device: drug eluting balloon catheter (trade name: Orchid)<br> <br> * Other names: drug eluting dilation catheter;|
| Active Comparator: common balloon catheter(uncoated drug)<br>use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery | Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)<br> <br> * Other names: common PTA catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Lumen Loss | measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal lumen diameter (MLD) | measure minimal lumen diameter (MLD) of target lesion | 6 months | 
| Restenosis rate of target vessel | stenosis over 50% is defined as restenosis | 6 months, 12 months, 18 months, 24months | 
| target lesion revascularization | target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion | 6 months, 12 months, 18 months, 24 months | 
| change in Rutherford stage | based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment Stage clinical symptom 0 asymptomatic mild claudication moderate claudication severe claudication ischemic rest pain minor tissue loss ulceration or gangrene | 6 months, 12 months, 18 months, 24 months | 
| change in ankle brachial index(ABI) | change in ankle brachial index(ABI) compared to pretreatment | 6 months | 
| major amputation | major amputation at the index limb(major amputation is defined as an amputation above the foot) | 6 months, 12 months, 18 months, 24 months | 
| Death | death of any cause | 12 months, 18 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting balloon catheter