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Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| platinum chromium everolimus-eluting stent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site | In hospital | |
| Target lesion revascularization | 12 month | |
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Inclusion Criteria:
A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
Male or non-pregnant female
Key lesion inclusion criteria as follows
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenya Nasu, MD, FACC | Contact | +81532373377 | yuyatomoya@gmail.com | |
| Yuji Oikawa, MD,PhD | Contact | +81532373377 | nasu@heart-center.or.jp |
| Name | Affiliation | Role |
|---|---|---|
| Yuji Oikawa, MD, PhD | The Cardiovascular Institute | Principal Investigator |
| Kenya Nasu, MD, FACC | Toyohashi Heart Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University Hospital | Not yet recruiting | Nagakute | Aichi-ken | 480-1195 | Japan |
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| Target vessel revascularization |
| 12 month |
| Myocardial infarction | 24 month |
| Cardiac death | 24 month |
| Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization | 24 month |
| Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC) | 24 month |
| Toyohashi Heart Center | Recruiting | Toyohashi | Aichi-ken | 441-8530 | Japan |
|
| Juntendo University Urayasu Hospital | Not yet recruiting | Urayasu | Chiba | 279-0021 | Japan |
|
| Saiseikai Fukuoka General Hospital | Not yet recruiting | Fukuoka | Fukuoka | 810-0001 | Japan |
|
| Kokura Memorial Hospital | Not yet recruiting | Kitakyushu | Fukuoka | 802-8555 | Japan |
|
| Hoshi General Hospital | Not yet recruiting | Kōriyama | Fukushima | 963-8501 | Japan |
|
| Southern Tohoku Research Institute for Neuroscience | Not yet recruiting | Kōriyama | Fukushima | 963-8563 | Japan |
|
| Gunma Prefectural Cardiovascular Center | Not yet recruiting | Maebashi | Gunma | 371-0004 | Japan |
|
| Gunma University Hospital | Not yet recruiting | Maebashi | Gunma | 371-8511 | Japan |
|
| Ota Memorial Hospital | Not yet recruiting | Ōta | Gunma | 373-8585 | Japan |
|
| Megumino Hospital | Not yet recruiting | Eniwa | Hokkaido | 061-1395 | Japan |
|
| JA Hokkaido Engaru Kosei General Hospital | Not yet recruiting | Monbetsu | Hokkaido | 099-0404 | Japan |
|
| Nayoro City General Hospital | Not yet recruiting | Nayoro | Hokkaido | 096-8511 | Japan |
|
| Sapporo Cardio Vascular Clinic | Not yet recruiting | Sapporo | Hokkaido | 007-0849 | Japan |
|
| Kansai Rosai Hospital | Not yet recruiting | Amagasaki | Hyōgo | 660-8511 | Japan |
|
| Kakogawa East City Hospital | Not yet recruiting | Kakogawa | Hyōgo | 685-0115 | Japan |
|
| Kobe University Hospital | Not yet recruiting | Kobe | Hyōgo | 650-0017 | Japan |
|
| Tsukuba Medical Center Hospital | Not yet recruiting | Tsukuba | Ibaragi | 305-8558 | Japan |
|
| Yokohama Rosai Hospital | Not yet recruiting | Yokohama | Kanagawa | 222-0036 | Japan |
|
| Yokohama City Minato Red Cross Hospital | Not yet recruiting | Yokohama | Kanagawa | 231-8682 | Japan |
|
| Saiseikai Kumamoto Hospital | Not yet recruiting | Kumamoto | Kumamoto | 861-4193 | Japan |
|
| Daini Okamoto General Hospital | Not yet recruiting | Uji | Kyoto | 611-0025 | Japan |
|
| Matsumoto Kyoritsu Hospital | Not yet recruiting | Matsumoto | Nagano | 390-8505 | Japan |
|
| Rinku General Medical Center | Not yet recruiting | Izumisano | Osaka | 598-8577 | Japan |
|
| Hokusetsu General Hospital | Not yet recruiting | Takatsuki | Osaka | 569-0852 | Japan |
|
| SHUWA General Hospital | Not yet recruiting | Kasukabe | Saitama | 344-0035 | Japan |
|
| Kasukabe Chuo General Hospital | Not yet recruiting | Kasukabe | Saitama | 344-0063 | Japan |
|
| TODA CHUO General Hospital | Not yet recruiting | Toda | Saitama | 335-0023 | Japan |
|
| Seirei Mikatahara General Hospital | Not yet recruiting | Hamamatsu | Shizuoka | 433-8558 | Japan |
|
| Ayase Heart Hospital | Not yet recruiting | Adachi-ku | Tokyo | 120-0006 | Japan |
|
| Tokyo Rinkai Hospital | Not yet recruiting | Edogawa-ku | Tokyo | 134-0086 | Japan |
|
| Itabashi Chuo Medical Center | Not yet recruiting | Itabashi-ku | Tokyo | 174-0051 | Japan |
|
| Katsushika Medical Center | Not yet recruiting | Katsushika-ku | Tokyo | 125-8506 | Japan |
|
| Tokyo-Kita Social Insurance Hospital | Not yet recruiting | Kita-ku | Tokyo | 115-0053 | Japan |
|
| The Cardiovascular Institute | Not yet recruiting | Minato-ku | Tokyo | 106-0031 | Japan |
|
| Tokyo Metropolitan Police Hospital | Not yet recruiting | Nakano-ku | Tokyo | 164-8541 | Japan |
|
| Tokyo Metropolitan Hiroo Hospital | Not yet recruiting | Shibuya-ku | Tokyo | 150-0013 | Japan |
|
| NTT Medical Center Tokyo | Not yet recruiting | Shinagawa-ku | Tokyo | 141-8625 | Japan |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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