Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease (DCB-SFA)

Seung-Whan Lee, M.D., Ph.D.

Status: Completed

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

Treatments: Device: Lutonix drug coated balloon; Device: IN.PACT drug coated balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02648334

AMCCV2015-08

Details and patient eligibility

About

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.

Enrollment: 443 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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443 participants in 2 patient groups

IN.PACT drug coated balloon

Active Comparator group

Description:

IN.PACT drug coated balloon

Treatment:

Device: IN.PACT drug coated balloon

Lutonix drug coated balloon

Experimental group

Description:

Lutonix drug coated balloon

Treatment:

Device: Lutonix drug coated balloon