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PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary endpoint at 1 year. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BuMA Supreme group | Experimental | Totally 1000 subjects combined the 220 subjects from randomized controlled trial(RCT) group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BuMA Supreme | Device | Stent platform: cobalt-chromium alloy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure | Target Lesion Failure(TLF) is defined as cardiac death, target vessel myocardial infarction(MI), or clinically-driven target lesion revascularization (TLR). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Stent implantation success rate | The stent implantation success rate includes device, lesion and clinical success rate. | 5 years after PCI |
| Device-oriented Composite Endpoint(DoCE) | Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven TLR (TLF). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, M.D. | Shanghai Zhongshan Hospital | Principal Investigator |
| Shubin Qiao, M.D. | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Yundai Chen, M.D. | Chinese PLA General Hospital | Study Director |
| Shaoping Nie, M.D. | Beijing Anzhen Hospital | Study Director |
| Yawei Xu, M.D. | Shanghai 10th People's Hospital | Study Director |
| Xiangqing Kong, M.D. | Jiangsu Proving Hospital | Study Director |
| Lang Li, M.D. | First Affiliated Hospital of Guangxi Medical University | Study Director |
| Xiangqian Shen, M.D. | Central South University | Study Director |
| Hui Li, M.D. | Daqing Oil Field Hospital | Study Director |
| Linghong Shen, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | 200032 | China |
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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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| 1, 6, 12 month, and annually up to 5 years post procedure |
| Patient-oriented Composite Endpoint (PoCE) | Patient-oriented Composite Endpoint is defined as all cause death, all MI, or any revascularization. | 1, 6, 12 month, and annually up to 5 years post procedure |
| Academic Research Consortium(ARC) defined stent thrombosis | Definite and probable stent thrombosis during acute, subacute, later and very late phase. | 5 years after PCI |
| Shanghai Chest Hospital |
| Study Director |
| Xi Su, M.D. | Wuhan Asia Heart Hospital | Study Director |
| Jiyan Chen, M.D. | Guangdong Provincial People's Hospital | Study Director |
| Genshang Ma, M.D. | Zhongda Hospital | Study Director |
| Xiaoshu Cheng, M.D. | Second Affiliated Hospital of Nanchang University | Study Director |
| Guosheng Fu, M.D. | Run Run Shaw Hospital | Study Director |
| Zesheng Xu, M.D. | Cangzhou Central Hospital | Study Director |
| Bin Li, M.D. | Hainan General Hospital | Study Director |
| Jianan Wang, M.D. | The Second Affiliated Hospital of Zhejiang University School of Medical College | Study Director |
| Haichu Yu, M.D. | The Affiliated Hospital of Qingdao University | Study Director |
| Guotai Shen, M.D. | Jiangxi Provincial People's Hopital | Study Director |
| Xiandong Li, M.D. | Shengjing Hospital | Study Director |
| Xianxian Zhao, M.D. | Changhai Hospital | Study Director |
| Tingbo Jiang, M.D. | The First Affiliated Hospital of Soochow University | Study Director |
| Mingzhe Li, M.D. | Xuzhou Central Hospital | Study Director |
| Zheng Zhang, M.D. | LanZhou University | Study Director |
| Bei Shi, M.D. | Zunyi Medical College | Study Director |
| Jinyu Huang, M.D. | Affiliated Hangzhou First People's Hospital ,Zhengzhou University School of Medicine | Study Director |
| Honghua Ye, M.D. | Hua Mei Hospital, University of Chinese Academy of Sciences(Ningbo No.2 Hospital) | Study Director |
| Guohai Su, M.D. | Jinan Central Hospital | Study Director |
| Hanjun Pei, M.D. | The First Affiliated Hospital of BaoTou Medical College | Study Director |
| Shaobin Jia, M.D. | General Hospital of Ningxia Medical University | Study Director |
| Chun Liang, M.D. | Shanghai Changzheng Hospital | Study Director |
| Ronghai Man, M.D. | Chifeng Municipal Hospital | Study Director |
| Jinchuan Yan, M.D. | Affiliated Hospital of Jiangsu University | Study Director |
| Xuchen Zhou, M.D. | The First Affiliated Hospital of Dalian Medical University | Study Director |
| Zhenyu Yang, M.D. | Wuxi People's Hospital | Study Director |
| Yuehui Yin, M.D. | The Second Affiliated Hospital of Chongqing Medical University | Study Director |
| Chunlai Zeng, M.D. | The Central Hospital of Lishui City | Study Director |
| Kejun Huang, M.D. | Henan Provincial Chest Hospital | Study Director |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |