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)
1 other identifier
interventional
237
1 country
1
Brief 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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 12, 2016
CompletedFirst Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedDecember 5, 2023
November 1, 2023
7.5 years
June 20, 2016
November 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Procedures lesion stenosis degree
Absence of restenosis \>50% by Duplex ultrasound, CT angiography, or catheter-based angiography
at 12 months
Secondary Outcomes (1)
Survival free from target vessel revascularization
12 months
Study Arms (2)
IVUS-guided group
EXPERIMENTALIntravascular ultrasound-guided intervention group
Angiography-guided group
ACTIVE COMPARATORAngiography-guided intervention group
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 39846915DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2016
First Posted
May 8, 2018
Study Start
May 12, 2016
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
December 5, 2023
Record last verified: 2023-11