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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
| Cordis US Corp. | INDUSTRY |
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In study-1, the purpose of this study is to compare the long-term outcome of provisional stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis " Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal growth on the strut and thrombus attachment."
Kissing balloon inflation brings asymmetrical expansion which may lead to a risk of disturbance of endothelialization. We will investigate the following issues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SES-KB | Active Comparator | Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation. |
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| SES-NK | Active Comparator | SES is deployed in the MV without kissing balloon inflation. |
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| EES-KB | Active Comparator | Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation. |
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| EES-NK | Active Comparator | EES is deployed in the MV without kissing balloon inflation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kissing balloon inflation | Procedure | Kissing balloon inflation following the MV stenting |
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| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| abnormal intimal coverage | Optical coherence tomography (OCT) is planned at the 9-month follow-up period. Unevenness of intimal growth, number of uncovered struts, and frequency of thrombus attachment are evaluated. | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoshinobu Murasato, MD, PhD | Contact | +81-930-24-8899 | murasato@shinyukuhashihospital.or.jp | |
| Yoshihisa Kinoshita, MD | Contact | +81-532-37-3377 | Ykinoshita@heart-center.or.jp |
| Name | Affiliation | Role |
|---|---|---|
| Yoshinobu Murasato, MD, PhD | New Yukuhashi Hospital | Principal Investigator |
| Yoshihisa Kinoshita, MD | Toyohashi Heart Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe University | Recruiting | Kobe | Japan |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| EES vs. SES | Device | Rapid endothelialization after EES deployment has been reported compared to that after SES deployment. |
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| Hyogo Medical University | Recruiting | Nishinomiya | Japan |
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| Toyohashi Heart Center | Recruiting | Toyohashi | Japan |
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| Saiseikai Yokohama Eastern Hospital | Recruiting | Yokohama | Japan |
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| New Yukuhashi hospital | Recruiting | Yukuhashi | 824-0026 | Japan |
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