Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PIONEER-II RCT trial is a prospective, multicenter, randomized, non-inferiority registry trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.
Realizing even more uniform and complete endothelial coverage, BuMA Supreme™ biodegradable drug coating coronary stent system comprises a new generation of biodegradable drug eluting stent under development by SINOMED. BuMA Supreme™ reconfigures BuMA™ DES utilizing a high caliber cobalt chromium platform coated with rapidly degrading PLGA scaffold.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BuMA Supreme group | Experimental | This group contains 319 subjects. Among them, 220 subjects will be implanted with regular specifications and 99 subjects with narrower, wider or longer ones. |
|
| BuMA™ group | Active Comparator | This group contains 220 subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BuMA Supreme | Device | Stent platform: cobalt-chromium alloy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| in-stent Late Lumen Loss, 9M | The primary endpoint is in-stent Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA). | QCA at 9-month follow-up window |
| Measure | Description | Time Frame |
|---|---|---|
| Stent implantation success rate | The stent implantation success rate includes device success, lesion success and clinical success. | 5 years after PCI |
| Binary restenosis rate | Binary restenosis was defined in every segment (proximal, distal, and stent) as a >50% diameter. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, M.D. | Shanghai Zhongshan Hospital | Principal Investigator |
| Yundai Chen, M.D. | Chinese PLA General Hospital | Principal Investigator |
| Shubin Qiao, M.D. | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BuMA™ |
| Device |
Stent platform: stainless steel |
|
| 9 months |
| in-segment LLL | to evaluate the in-sigment Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA). | 9 months |
| diameter stenosis degree | to compare the lumen diameter at 9-month after stent implantation with the baseline diameter as assessed by off-line quantitative coronary angiography (QCA). | 9 months |
| Device-oriented Composite Endpoint (DoCE) | Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR). | 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 myocardial ischemia (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 |
| 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 Sheng, M.D. | Jiangxi Provincial People's Hopital | Study Director |
| Xiandong Li, M.D. | Shengjing Hospital | Study Director |
| Tingbo Jiang, M.D. | The First Affiliated Hospital of Soochow University | Study Director |
| Kui Chen, M.D. | The First Affiliated Hospital of Zhengzhou University | Study Director |
| Hua Wang, M.D. | West China Hospital | Study Director |
| Menghong Wang, M.D. | The First Affiliated Hospital of Nanchang University | 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 |
| Manhua Chen, M.D. | Wuhan Central Hospital | Study Director |
| Yongjun Li, M.D. | The Second Hospital of Hebei Medical University | Study Director |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |