Angioplasty, BalloonDCB-SFANCT02648334
Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease
A study testing IN.PACT drug coated balloon and Lutonix drug coated balloon in people with Angioplasty, Balloon and Catheterization, Peripheral, run by Seung-Whan Lee, M.D., Ph.D. at 14 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Angioplasty, Balloon, Catheterization, Peripheral, Popliteal Artery
- What is being tested?
- IN.PACT drug coated balloon and Lutonix drug coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 10 Nov 2016to 7 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Hallym University Sacred Heart Hospital
Anyang
Gyeongsang National University Changwon Hospital
Changwon
Kangwon National University Hospital
Chuncheon
Chungnam National University Hospital
Daejeon
Myongji Hospital
Goyang-si
Seoul national university Bundang hospital
Gyeonggi-do
Jesushospital
Jeonju
Dong-A Medical Center
Pusan
Inje University Pusan Paik Hospital
Pusan
Veterans Hospital
Pusan
Chungnam National University Sejong Hospital
Sejong
Asan Medical Center
Seoul
Kangbuk Samsung Medical Center
Seoul
Veterans Hospital Service Medical Center
Seoul
About this study
Official title: 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.
- Being tested
- IN.PACT drug coated balloon, Lutonix drug coated balloon
- Keywords
- Drug-Coated Balloon, Superficial Femoral artery, popliteal peripheral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN.PACT drug coated balloonDevice
Lutonix drug coated balloonDevice
| Study group | Role | What they receive |
|---|---|---|
| IN.PACT drug coated balloon | Active comparator | IN.PACT drug coated balloon Receives: Device: IN.PACT drug coated balloon |
| Lutonix drug coated balloon | Experimental | Lutonix drug coated balloon Receives: Device: Lutonix drug coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
the event rate of composite event
all cause death, revascularization due to amputation or clinical evidence
Measured: 1 year
Secondary outcomes (10)
all cause death
Measured: 2 years
cardiac death
Measured: 2 years
myocardial infarction
Measured: 2 years
stroke
Measured: 2 years
amputation of target limb
Measured: 2 years
target lesion revascularization
Measured: 2 years
The change of Rutherford classification
Measured: 2 years
The change of ABI(ankle-brachial index) score
Measured: 2 years
MACE
major adverse cardiac event(death, myocardial infarction, stroke)
Measured: 2 years
thrombosis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start10 Nov 2016
- Primary completion19 Jan 2023
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioplasty, BalloonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Whan Lee, M.D., Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seung-Whan Lee, M.D., Ph.D., Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648334
- Sponsor's protocol ID
- AMCCV2015-08
- Acronym
- DCB-SFA
- Status last verified
- Aug 2024
- First submitted
- 5 Jan 2016
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Drug-Coated Balloons for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease: Prospective, Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02648334
- Acronym / sponsor ID
- DCB-SFA / AMCCV2015-08
- Keywords
- Drug-Coated Balloon, Superficial Femoral artery, popliteal peripheral Artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Seung-Whan Lee, M.D., Ph.D.University, hospital or other
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IN.PACT drug coated balloon | Active comparator | Device: IN.PACT drug coated balloonIN.PACT drug coated balloon |
| Lutonix drug coated balloon | Experimental | Device: Lutonix drug coated balloonLutonix drug coated balloon |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Acute stage
- Acute thrombosis in target limb or target vessel
- Failure to guide wire pass
- Distal outflow
- Lesion with poor inflow
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN.PACT drug coated balloon | Device | IN.PACT drug coated balloon |
| Lutonix drug coated balloon | Device | Lutonix drug coated balloon |
Primary outcome
the event rate of composite event
Time frame: 1 year
all cause death, revascularization due to amputation or clinical evidence
10 secondary outcomes
all cause death
Time frame: 2 years
cardiac death
Time frame: 2 years
myocardial infarction
Time frame: 2 years
stroke
Time frame: 2 years
amputation of target limb
Time frame: 2 years
target lesion revascularization
Time frame: 2 years
The change of Rutherford classification
Time frame: 2 years
The change of ABI(ankle-brachial index) score
Time frame: 2 years
MACE
Time frame: 2 years
thrombosis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No. This is not publicly funded trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IN.PACT drug coated balloon and Lutonix drug coated balloon in people with Angioplasty, Balloon and Catheterization, Peripheral, run by Seung-Whan Lee, M.D., Ph.D. at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the event rate of composite event (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.