DCB Compared Stenting in Popliteal Lesions

Study Overview
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Brief Summary
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This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.

Official Title
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The Comparison of Drug-coated Balloon With Stent Deployment in Popliteal Atherosclerotic Occlusive Lesions

Conditions
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Popliteal Stenosis, Popliteal Artery Occlusion, Diabetes

Intervention / Treatment
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* Device: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)
* Device: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Symptomatic peripheral artery disease: Moderate or severe claudication (Rutherford category 2 or 3) Critical limb ischemia (Rutherford category 4 or 5) Atherosclerotic popliteal artery disease (stenosis > 50%) Patients with signed informed consent Exclusion Criteria: Acute critical limb ischemia Severe critical limb ischemia (Rutherford category 6) Involvement of SFA disease with stenosis Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk). Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent Age > 80 years Severe hepatic dysfunction (> 3 times normal reference values) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis LVEF < 40% or clinically overt congestive heart failure Pregnant women or women with potential childbearing Life expectancy <1 year due to comorbidity Previous bypass surgery or stenting for the target popliteal artery Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drug-coating balloon<br>drug-coating balloon (Orchid) intervention | Device: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)<br>* for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.<br>|
| Active Comparator: stent deployment<br>metal bare stent intervention | Device: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)<br>* for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency of claudicant patients | Claudicant patients (Rutherford C1-3), primary patency defined as PSVR（peak systolic velocity ratio) ≤2.4, absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months | 12 months after the index procedure | 
| Salvage limb rate (for CLI patients) | Limb Salvage is defined as the freedom from secondary major amputation | 12 months after the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rutherford classification |  | 12 months | 
| ABI | Ankle Brachial index | 12 months | 
| TcpO2 | transcutaneous oxygen pressure | 12 months | 
| Wagnar classification | incision healing information of Rutherford C5-6 patients | 12 months | 
| Target vessel revascularization rate | frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel | 12 months | 
| Index Limb Ischemia at 12-month Follow up | Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6. | 12 months | 
| Major Adverse Events at 12-month Post Procedure | Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization, and significant embolic events, which were defined as causing end-organ damage. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-coating balloon, stent, popliteal artery, atherosclerotic occlusion