This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA) using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral Artery disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
443
Hallym University Sacred Heart Hospital
Anyang, South Korea
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
the event rate of composite event
all cause death, revascularization due to amputation or clinical evidence
Time frame: 1 year
all cause death
Time frame: 2 years
cardiac death
Time frame: 2 years
myocardial infarction
Time frame: 2 years
stroke
Time frame: 2 years
amputation of target limb
Time frame: 2 years
target lesion revascularization
Time frame: 2 years
The change of Rutherford classification
Time frame: 2 years
The change of ABI(ankle-brachial index) score
Time frame: 2 years
MACE
major adverse cardiac event(death, myocardial infarction, stroke)
Time frame: 2 years
thrombosis
Time frame: 2 years
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Chungnam National University Hospital
Daejeon, South Korea
Myongji Hospital
Goyang-si, South Korea
Seoul national university Bundang hospital
Gyeonggi-do, South Korea
Jesushospital
Jeonju, South Korea
Dong-A Medical Center
Pusan, South Korea
Inje University Pusan Paik Hospital
Pusan, South Korea
Veterans Hospital
Pusan, South Korea
...and 4 more locations