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

Seung-Whan Lee, M.D., Ph.D.14 sites in 1 country443 target enrollmentNovember 10, 2016

ConditionsAngioplasty, Balloon Catheterization, Peripheral Popliteal Artery Femoral Artery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Angioplasty, Balloon
Sponsor: Seung-Whan Lee, M.D., Ph.D.
Enrollment: 443
Locations: 14
Primary Endpoint: the event rate of composite event
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 10, 2016

End Date

August 7, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor Investigator

Principal Investigator

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

Division of Cardiology

Asan Medical Center

Eligibility Criteria

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