The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
Drug-eluting balloon (DEB) have emerged as a potential alternative to overcome the limitations of drug-eluting stents such as restenosis or stent thrombosis. DEB angioplasty is proven to be effective clinically for the treatment of in-stent restenosis. However, DEB for de novo lesions, especially in small vessels is less studied. The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Balloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length \< 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty.
Gachon University Gil Medical Center
Incheon, South Korea
RECRUITINGLate loss
Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary
Time frame: 9±1 months
Binary restenosis rate
Restenosis rate of the target lesion at the follow-up quantitative coronary angiography
Time frame: 9±1 months
Neointimal hyperplasia
Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam
Time frame: 9±1 months
Clinical outcomes
Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion
Time frame: 9±1 months
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