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

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

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.

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