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

Primary Purpose

Angioplasty, Balloon, Catheterization, Peripheral, Popliteal Artery

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
IN.PACT drug coated balloon
Lutonix drug coated balloon
Sponsored by
Seung-Whan Lee, M.D., Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioplasty, Balloon focused on measuring Drug-Coated Balloon, Superficial Femoral artery, popliteal peripheral Artery

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 20 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

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
  • Last stage of renal failure with dialysis
  • Previous treatment with atherectomy, laser, cryoplasty, scoring, cutting, balloon angioplasty
  • Pregnant or breast feeding woman or disagree with contraception

Sites / Locations

  • Hallym University Sacred Heart Hospital
  • Gyeongsang National University Changwon Hospital
  • Kangwon National University Hospital
  • Chungnam National University Hospital
  • Myongji Hospital
  • Seoul national university Bundang hospital
  • Jesushospital
  • Dong-A Medical Center
  • Inje University Pusan Paik Hospital
  • Veterans Hospital
  • Chungnam National University Sejong Hospital
  • Asan Medical Center
  • Kangbuk Samsung Medical Center
  • Veterans Hospital Service Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IN.PACT drug coated balloon

Lutonix drug coated balloon

Arm Description

IN.PACT drug coated balloon

Lutonix drug coated balloon

Outcomes

Primary Outcome Measures

the event rate of composite event
all cause death, revascularization due to amputation or clinical evidence

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2016
Last Updated
May 31, 2023
Sponsor
Seung-Whan Lee, M.D., Ph.D.
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1. Study Identification

Unique Protocol Identification Number
NCT02648334
Brief Title
Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Whan Lee, M.D., Ph.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioplasty, Balloon, Catheterization, Peripheral, Popliteal Artery, Femoral Artery
Keywords
Drug-Coated Balloon, Superficial Femoral artery, popliteal peripheral Artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1080 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IN.PACT drug coated balloon
Arm Type
Active Comparator
Arm Description
IN.PACT drug coated balloon
Arm Title
Lutonix drug coated balloon
Arm Type
Experimental
Arm Description
Lutonix drug coated balloon
Intervention Type
Device
Intervention Name(s)
IN.PACT drug coated balloon
Intervention Type
Device
Intervention Name(s)
Lutonix drug coated balloon
Primary Outcome Measure Information:
Title
the event rate of composite event
Description
all cause death, revascularization due to amputation or clinical evidence
Time Frame
1 year
Secondary Outcome Measure Information:
Title
all cause death
Time Frame
2 years
Title
cardiac death
Time Frame
2 years
Title
myocardial infarction
Time Frame
2 years
Title
stroke
Time Frame
2 years
Title
amputation of target limb
Time Frame
2 years
Title
target lesion revascularization
Time Frame
2 years
Title
The change of Rutherford classification
Time Frame
2 years
Title
The change of ABI(ankle-brachial index) score
Time Frame
2 years
Title
MACE
Description
major adverse cardiac event(death, myocardial infarction, stroke)
Time Frame
2 years
Title
thrombosis
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
Gyeongsang National University Changwon Hospital
City
Changwon
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Goyang-si
Country
Korea, Republic of
Facility Name
Seoul national university Bundang hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Jesushospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Dong-A Medical Center
City
Pusan
Country
Korea, Republic of
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Veterans Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Chungnam National University Sejong Hospital
City
Sejong
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Veterans Hospital Service Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is not publicly funded trial.

Learn more about this trial

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

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