Femoropopliteal Artery DiseaseNCT03517904
Comparison of Intravascular Ultrasound-Guided vs. Angiography-guided Angioplasty and Dual-antiplatelet v. Triple-antiplatelet Therapy for Outcomes of Drug-coated Balloon in the Treatment of Femoropopliteal Artery Disease (IVUS-DCB)
A study testing IVUS-guided angioplasty and Angiography-guided angioplasty in people with Femoropopliteal Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Prospective, randomized, controlled, multi-center study A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided intervention group. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Femoropopliteal Artery Disease
- What is being tested?
- IVUS-guided angioplasty and Angiography-guided angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2016to 31 Oct 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 years or older
- Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5)
- Femoropopliteal artery disease (stenosis > 50%)
- ABI <0.9
- Patients with signed informed consent
Who cannot join
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
- Patients requiring oral anticoagulation using warfarin or NOAC
- Age > 85 years
- Severe hepatic dysfunction (> 3 times normal reference values)
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- Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- LVEF < 40% or clinically overt congestive heart failure
- Pregnant women or women with potential childbearing
- Life expectancy <1 year due to comorbidity
- Previous bypass surgery or stenting in the target femoropopliteal artery
- Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752
About this study
- Prospective, randomized, controlled, multi-center study
- A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria.
- Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided intervention group.
- Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional
- All patients will be treated with drug-coated balloons (In.PACT Admiral) for femoropopliteal lesions.
- Bare metal self-expandable stents will be used in addition according to findings of IVUS or angiography such as severity of arterial dissection or residual stenosis.
- Patients will be followed clinically for 1 year after the procedure.
- Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.
- Conditions
- Femoropopliteal Artery Disease
- Being tested
- IVUS-guided angioplasty, Angiography-guided angioplasty
- Keywords
- Femoropopliteal artery disease, drug-coated balloon, angioplasty, antiplatelet therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS-guided angioplastyProcedure or surgery
Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. IVUS evaluation will be performed before predilation and after DEB treatment. In cases of stent implantation, additional IVUS evaluation will be performed after stenting. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of IVUS measurement. Implantation of stents will be left to the operator's decision after reviewing IVUS findings after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended.
Angiography-guided angioplastyProcedure or surgery
Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of angiogram. Implantation of stents will be left to the operator's decision after reviewing the angiogram after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended.
| Study group | Role | What they receive |
|---|---|---|
| IVUS-guided group | Experimental | Intravascular ultrasound-guided intervention group Receives: Procedure: IVUS-guided angioplasty |
| Angiography-guided group | Active comparator | Angiography-guided intervention group Receives: Procedure: Angiography-guided angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedures lesion stenosis degree
Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography
Measured: at 12 months
Secondary outcomes (1)
Survival free from target vessel revascularization
Survival free from repeat intervention or surgical treatment due to loss of patency at the target vessel
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start12 May 2016
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoropopliteal Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517904
- Sponsor's protocol ID
- 1-2015-0093
- Status last verified
- Nov 2023
- First submitted
- 20 Jun 2016
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lee SJ, Kim TH, Lee JH, Ahn CM, Lee SH, Lee YJ, Kim BK, Hong MK, Jang Y, Park HW, Jang JY, Park JH, Kim SH, Im E, Park SH, Choi D, Ko YG; IVUS-DCB Investigators. Intravascular Ultrasound-Guided vs Angiography-Guided Drug-Coated Balloon Angioplasty in Patients With Complex Femoropopliteal Artery Disease. JACC Cardiovasc Interv. 2025 Mar 10;18(5):558-569. doi: 10.1016/j.jcin.2024.10.052. Epub 2025 Jan 22.
PubMed 39846915
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravascular Ultrasound-Guided vs. Angiography-guided Angioplasty and Dual-antiplatelet v. Triple-antiplatelet Therapy for Outcomes of Drug-coated Balloon in the Treatment of Femoropopliteal Artery Disease (IVUS-DCB)
- ClinicalTrials.gov ID
- NCT03517904
- Acronym / sponsor ID
- 1-2015-0093
- Conditions
- Femoropopliteal Artery Disease
- Keywords
- Femoropopliteal artery disease, drug-coated balloon, angioplasty, antiplatelet therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 May 2016 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 8 May 2018 (actual)
- 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.
- Prospective, randomized, controlled, multi-center study
- A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria.
- Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided intervention group.
- Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional
- All patients will be treated with drug-coated balloons (In.PACT Admiral) for femoropopliteal lesions.
- Bare metal self-expandable stents will be used in addition according to findings of IVUS or angiography such as severity of arterial dissection or residual stenosis.
- Patients will be followed clinically for 1 year after the procedure.
- Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS-guided group | Experimental | Procedure: IVUS-guided angioplastyIntravascular ultrasound-guided intervention group |
| Angiography-guided group | Active comparator | Procedure: Angiography-guided angioplastyAngiography-guided intervention group |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 19 years or older
- Symptomatic peripheral artery disease:
- Femoropopliteal artery disease (stenosis > 50%)
- ABI <0.9
- Patients with signed informed consent
Key exclusion criteria (12 listed)
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
- Patients requiring oral anticoagulation using warfarin or NOAC
- Age > 85 years
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 |
|---|---|---|
| IVUS-guided angioplastyAngioplasty using drug-coated balloon (DCB) will be performed in standard manner. IVUS evaluation will be performed before predilation and after DEB treatment. In cases of stent implantation, additional IVUS evaluation will be performed after stenting. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of IVUS measurement. Implantation of stents will be left to the operator's decision after reviewing IVUS findings after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended. | Procedure or surgery | IVUS-guided group |
| Angiography-guided angioplastyAngioplasty using drug-coated balloon (DCB) will be performed in standard manner. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of angiogram. Implantation of stents will be left to the operator's decision after reviewing the angiogram after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended. | Procedure or surgery | Angiography-guided group |
Primary outcome
Procedures lesion stenosis degree
Time frame: at 12 months
Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography
1 secondary outcome
Survival free from target vessel revascularization
Time frame: 12 months
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 5 Dec 2023.
- Derived from this study: PubMed 39846915Lee SJ, Kim TH, Lee JH, Ahn CM, Lee SH, Lee YJ, Kim BK, Hong MK, Jang Y, Park HW, Jang JY, Park JH, Kim SH, Im E, Park SH, Choi D, Ko YG; IVUS-DCB Investigators. Intravascular Ultrasound-Guided vs Angiography-Guided Drug-Coated Balloon Angioplasty in Patients With Complex Femoropopliteal Artery Disease. JACC Cardiovasc Interv. 2025 Mar 10;18(5):558-569. doi: 10.1016/j.jcin.2024.10.052. Epub 2025 Jan 22.
- Individual participant dataSharing planned: Undecided
Related trials for Femoropopliteal Artery Disease
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EVERO Drug-coated Balloon (DCB) Randomized Trial
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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
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Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
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DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS-guided angioplasty and Angiography-guided angioplasty in people with Femoropopliteal Artery Disease, run by Yonsei University at 1 site 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 12 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Procedures lesion stenosis degree (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03517904, which also lists 1 linked publication.
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 5 Dec 2023.