Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, Balloon angioplasty, Drug-eluting balloon
Brief summary
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.
Detailed description
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.
Interventions
DEVICESeQuent® Please Drug-eluting balloon
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.
Sponsors
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Inje University
Chonnam National University Hospital
Ulsan University Hospital
Jeju National University Hospital
Daegu Catholic University Medical Center
Chungbuk National University
Dankook University
The Catholic University of Korea
Kwandong University Myongji Hospital
Kosin University Gospel Hospital
Keimyung University Dongsan Medical Center
Soonchunhyang University Hospital
National Health Insurance Service Ilsan Hospital
Saint Carollo General Hospital
Chuncheon Sacred Heart Hospital
Sejong General Hospital
Cheju Halla General Hospital
Wonkwang University
Konyang University Hospital
Gangnam Severance Hospital
Hallym University Medical Center
Chonbuk National University Hospital
Korea University Guro Hospital
Gachon University Gil Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 19 years * Patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length \< 25 mm) * Informed consent
Exclusion criteria
* Chronic total obstruction lesion * Severe calcified lesion * Left main coronary lesion * Lesion having intravascular thrombus * Shock status from any cause including cardiogenic shock * Left ventricular ejection fraction \< 30% * Need for coronary artery bypass surgery * Allergic reaction for paclitaxel * Severe allergic for contrast agent (Visipaque) or statin * Pregnancy, breastfeeding or Expectation for pregnancy in women of childbearing age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late loss | 9±1 months | Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary |
| Binary restenosis rate | 9±1 months | Restenosis rate of the target lesion at the follow-up quantitative coronary angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal hyperplasia | 9±1 months | Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam |
| Clinical outcomes | 9±1 months | Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion |
Countries
South Korea
Contacts
Primary ContactWoong Chul Kang, M.D.
Outcome results
None listed