Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease

Study Overview
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Brief Summary
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This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA) using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral Artery disease.

Official Title
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Randomized Comparison of Drug-Coated Balloons for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease: Prospective, Multicenter, Randomized, Controlled Trial

Conditions
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Angioplasty, Balloon, Catheterization, Peripheral, Popliteal Artery, Femoral Artery

Intervention / Treatment
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* Device: IN.PACT drug coated balloon
* Device: Lutonix drug coated balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 and above Subject with claudication or critical limb ischemia(Rutherford classification level 2 5) Subject with total occlusion or stenosis ≥70%(de novo, restenosis) Vessel diameter 4 6mm Success to guide wire pass Patients who don't have known hypersensitivity or allergy for dual-platelets Willing and able to provide informed written consent Exclusion Criteria: Acute stage Acute thrombosis in target limb or target vessel Failure to guide wire pass Distal outflow Lesion with poor inflow Life expectancy ≤ 2 years Allergic to paclitaxel Pregnant or breast feeding woman or disagree with contraception or having children

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Active Comparator: IN.PACT drug coated balloon<br>IN.PACT drug coated balloon | Device: IN.PACT drug coated balloon<br> <br> |
| Experimental: Lutonix drug coated balloon<br>Lutonix drug coated balloon | Device: Lutonix drug coated balloon<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the event rate of composite event | all cause death, revascularization due to amputation or clinical evidence | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause death |  | 2 years | 
| cardiac death |  | 2 years | 
| myocardial infarction |  | 2 years | 
| stroke |  | 2 years | 
| amputation of target limb |  | 2 years | 
| target lesion revascularization |  | 2 years | 
| The change of Rutherford classification |  | 2 years | 
| The change of ABI(ankle-brachial index) score |  | 2 years | 
| MACE | major adverse cardiac event(death, myocardial infarction, stroke) | 2 years | 
| thrombosis |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Coated Balloon, Superficial Femoral artery, popliteal peripheral Artery