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

Not Applicable

Completed

• Conditions: Angioplasty, Balloon; Catheterization, Peripheral; Popliteal Artery; Femoral Artery
• Interventions: Device: IN.PACT drug coated balloon; Device: Lutonix drug coated balloon

• Registration Number: NCT02648334
• Lead Sponsor: Seung-Whan Lee, M.D., Ph.D.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Study Start: 2016-11-10
• Primary Completion: 2023-01-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Study Completion: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 443

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IN.PACT drug coated balloon	IN.PACT drug coated balloon	IN.PACT drug coated balloon
Lutonix drug coated balloon	Lutonix drug coated balloon	Lutonix drug coated balloon

Primary Outcome Measures

Name	Time	Method
the event rate of composite event	1 year	all cause death, revascularization due to amputation or clinical evidence

Secondary Outcome Measures

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

Trial Locations

Locations (14)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Gyeongsang National University Changwon Hospital; 🇰🇷 Changwon, Korea, Republic of

Myongji Hospital; 🇰🇷 Goyang-si, Korea, Republic of

Seoul national university Bundang hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Dong-A Medical Center; 🇰🇷 Pusan, Korea, Republic of

Inje University Pusan Paik Hospital; 🇰🇷 Pusan, Korea, Republic of

Veterans Hospital Service Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Veterans Hospital; 🇰🇷 Pusan, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Jesushospital; 🇰🇷 Jeonju, Korea, Republic of

Chungnam National University Sejong Hospital; 🇰🇷 Sejong, Korea, Republic of