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)

• 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.

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)