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

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.

Study Overview

• Status: Completed
• Conditions: Catheterization, Peripheral; Popliteal Artery; Angioplasty, Balloon; Femoral Artery
• Intervention / Treatment: Device: IN.PACT drug coated balloon; Device: Lutonix drug coated balloon

• Study Type: Interventional
• Enrollment (Actual): 443
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IN.PACT drug coated balloon	Device: IN.PACT drug coated balloon
Experimental: Lutonix drug coated balloon	Device: Lutonix drug coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the event rate of composite event	all cause death, revascularization due to amputation or clinical evidence	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seung-Whan Lee, M.D., Ph.D.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2016
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): August 7, 2024

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimated): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Drug-Coated Balloon; Superficial Femoral artery; popliteal peripheral Artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: AMCCV2015-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not publicly funded trial.