* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
237
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.
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
Procedures lesion stenosis degree
Absence of restenosis \>50% by Duplex ultrasound, CT angiography, or catheter-based angiography
Time frame: at 12 months
Survival free from target vessel revascularization
Survival free from repeat intervention or surgical treatment due to loss of patency at the target vessel
Time frame: 12 months
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