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)

Study Overview
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Brief Summary
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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
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Femoropopliteal Artery Disease

Intervention / Treatment
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* Procedure: IVUS-guided angioplasty
* Procedure: Angiography-guided angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVUS-guided group<br>Intravascular ultrasound-guided intervention group | Procedure: IVUS-guided angioplasty<br>* 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.<br>|
| Active Comparator: Angiography-guided group<br>Angiography-guided intervention group | Procedure: Angiography-guided angioplasty<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedures lesion stenosis degree | Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival free from target vessel revascularization | Survival free from repeat intervention or surgical treatment due to loss of patency at the target vessel | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoropopliteal artery disease, drug-coated balloon, angioplasty, antiplatelet therapy