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| Name | Class |
|---|---|
| Chung-Ang University Hospital | OTHER |
| Inje University | OTHER |
| Chonnam National University Hospital | OTHER |
| Ulsan University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting balloon | Experimental | Balloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter > 2.25 mm and ≤ 2.75 mm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SeQuent® Please Drug-eluting balloon | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Late loss | Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary | 9±1 months |
| Binary restenosis rate | Restenosis rate of the target lesion at the follow-up quantitative coronary angiography | 9±1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neointimal hyperplasia | Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam | 9±1 months |
| Clinical outcomes | Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Woong Chul Kang, M.D. | Contact | +82-32-460-3663 | kangwch@gilhospital.com |
| Name | Affiliation | Role |
|---|---|---|
| Woong Chul Kang, M.D. | Gachon University Gil Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gachon University Gil Medical Center | Recruiting | Incheon | 405-760 | South Korea |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Jeju National University Hospital | OTHER |
| Daegu Catholic University Medical Center | OTHER |
| Chungbuk National University | OTHER |
| Dankook University | OTHER |
| The Catholic University of Korea | OTHER |
| Kwandong University Myongji Hospital | UNKNOWN |
| Kosin University Gospel Hospital | OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
| Soonchunhyang University Hospital | OTHER |
| National Health Insurance Service Ilsan Hospital | OTHER |
| Saint Carollo General Hospital | UNKNOWN |
| Chuncheon Sacred Heart Hospital | OTHER |
| Sejong General Hospital | OTHER |
| Cheju Halla General Hospital | OTHER |
| Wonkwang University | OTHER |
| Konyang University Hospital | OTHER |
| Gangnam Severance Hospital | OTHER |
| Hallym University Medical Center | OTHER |
| Chonbuk National University Hospital | OTHER |
| Korea University Guro Hospital | OTHER |
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|
| 9±1 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |