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NCT02648334 Clinical Trial

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

Catheterization, Peripheral Clinical Trial

— DCB-SFA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02648334
Other study ID # AMCCV2015-08
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 10, 2016
Est. completion date December 2027

Study information
Verified date November 2023
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1080
Est. completion date December 2027
Est. primary completion date September 5, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• IN.PACT drug coated balloon

• Lutonix drug coated balloon

Locations
Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital Anyang
Korea, Republic of Gyeongsang National University Changwon Hospital Changwon
Korea, Republic of Kangwon National University Hospital Chuncheon
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Myongji Hospital Goyang-si
Korea, Republic of Seoul national university Bundang hospital Gyeonggi-do
Korea, Republic of Jesushospital Jeonju
Korea, Republic of Dong-A Medical Center Pusan
Korea, Republic of Inje University Pusan Paik Hospital Pusan
Korea, Republic of Veterans Hospital Pusan
Korea, Republic of Chungnam National University Sejong Hospital Sejong
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kangbuk Samsung Medical Center Seoul
Korea, Republic of Veterans Hospital Service Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seung-Whan Lee, M.D., Ph.D.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary the event rate of composite event all cause death, revascularization due to amputation or clinical evidence 1 year
Secondary all cause death 2 years
Secondary cardiac death 2 years
Secondary myocardial infarction 2 years
Secondary stroke 2 years
Secondary amputation of target limb 2 years
Secondary target lesion revascularization 2 years
Secondary The change of Rutherford classification 2 years
Secondary The change of ABI(ankle-brachial index) score 2 years
Secondary MACE major adverse cardiac event(death, myocardial infarction, stroke) 2 years
Secondary thrombosis 2 years
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