A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)
NCT ID: NCT02698852
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1000 participants
INTERVENTIONAL
2015-12-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BuMA Supreme group
Totally 1000 subjects combined the 220 subjects from randomized controlled trial(RCT) group
BuMA Supreme
Stent platform: cobalt-chromium alloy
Interventions
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BuMA Supreme
Stent platform: cobalt-chromium alloy
Eligibility Criteria
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Inclusion Criteria
2. Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI
3. Target lesion is primary and de-novo coronary artery disease
4. The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated)
5. Lesion diameter stenosis ≥70% (visually estimated)
6. For each target lesion, same stent implantation only
7. Acceptable candidate for Coronary Artery Bypass Grafting(CABG)
8. Understand the study purpose, willing to participate and sign the letter of consent, agrees to the follow-up visits including a 9 month angiographic follow-up
Exclusion Criteria
2. Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion
3. More than 3 stents required
4. Patients refuse to be implanted stent
5. Calcified lesion failed in pre-dilation, twisted lesion and lesion unsuitable for stent delivery and expansion
6. In-stent restenosis
7. Planned percutaneous coronary intervention (PCI) within 3 months post procedure
8. Other stents implanted within 1 year
9. Severe heart failure (NYHA above III) or left ventricle ejection fraction(EF) \<40%
10. Renal function damage, blood creatinine \> 176.82 μmol/L
11. Bleeding tendency, active peptic ulcer disease, cerebral or subarachnoid hemorrhage, cerebral apoplexy within half year and contraindication for any anti-platelet or anticoagulation agents
12. Allergic to drugs or agents used in stent or protocol (PLGA, sirolimus, aspirin, clopidogrel, contrast agent, cobalt, nickel, chromium, iron, wolfram et. al.)
13. Life expectation \< 12 months
14. Have not reached the primary end point when participating in other trial
15. Poor compliance to the protocol
16. Heart implantation cases
18 Years
75 Years
ALL
No
Sponsors
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Sino Medical Sciences Technology Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Junbo Ge, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Shubin Qiao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Yundai Chen, M.D.
Role: STUDY_DIRECTOR
Chinese PLA General Hospital
Shaoping Nie, M.D.
Role: STUDY_DIRECTOR
Beijing Anzhen Hospital
Yawei Xu, M.D.
Role: STUDY_DIRECTOR
Shanghai 10th People's Hospital
Xiangqing Kong, M.D.
Role: STUDY_DIRECTOR
Jiangsu Proving Hospital
Lang Li, M.D.
Role: STUDY_DIRECTOR
First Affiliated Hospital of Guangxi Medical University
Xiangqian Shen, M.D.
Role: STUDY_DIRECTOR
Central South University
Hui Li, M.D.
Role: STUDY_DIRECTOR
Daqing oilfield general hospital
Linghong Shen, M.D.
Role: STUDY_DIRECTOR
Shanghai Chest Hospital
Xi Su, M.D.
Role: STUDY_DIRECTOR
Wuhan Asia Heart Hospital
Jiyan Chen, M.D.
Role: STUDY_DIRECTOR
Guangdong Provincial People's Hospital
Genshang Ma, M.D.
Role: STUDY_DIRECTOR
Zhongda Hospital
Xiaoshu Cheng, M.D.
Role: STUDY_DIRECTOR
Second Affiliated Hospital of Nanchang University
Guosheng Fu, M.D.
Role: STUDY_DIRECTOR
Run Run Shaw Hospital
Zesheng Xu, M.D.
Role: STUDY_DIRECTOR
Cangzhou Central Hospital
Bin Li, M.D.
Role: STUDY_DIRECTOR
Hainan General Hospital
Jianan Wang, M.D.
Role: STUDY_DIRECTOR
The Second Affiliated Hospital of Zhejiang University School of Medical College
Haichu Yu, M.D.
Role: STUDY_DIRECTOR
The Affiliated Hospital of Qingdao University
Guotai Shen, M.D.
Role: STUDY_DIRECTOR
Jiangxi Provincial People's Hopital
Xiandong Li, M.D.
Role: STUDY_DIRECTOR
Shengjing Hospital
Xianxian Zhao, M.D.
Role: STUDY_DIRECTOR
Changhai Hospital
Tingbo Jiang, M.D.
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Soochow University
Mingzhe Li, M.D.
Role: STUDY_DIRECTOR
Xuzhou Central Hospital
Zheng Zhang, M.D.
Role: STUDY_DIRECTOR
LanZhou University
Bei Shi, M.D.
Role: STUDY_DIRECTOR
Zunyi Medical College
Jinyu Huang, M.D.
Role: STUDY_DIRECTOR
Affiliated Hangzhou First People's Hospital ,Zhengzhou University School of Medicine
Honghua Ye, M.D.
Role: STUDY_DIRECTOR
Hua Mei Hospital, University of Chinese Academy of Sciences(Ningbo No.2 Hospital)
Guohai Su, M.D.
Role: STUDY_DIRECTOR
Jinan Central Hospital
Hanjun Pei, M.D.
Role: STUDY_DIRECTOR
The First Affiliated Hospital of BaoTou Medical College
Shaobin Jia, M.D.
Role: STUDY_DIRECTOR
General Hospital of Ningxia Medical University
Chun Liang, M.D.
Role: STUDY_DIRECTOR
Shanghai Changzheng Hospital
Ronghai Man, M.D.
Role: STUDY_DIRECTOR
Chifeng Municipal Hospital
Jinchuan Yan, M.D.
Role: STUDY_DIRECTOR
Affiliated Hospital of Jiangsu University
Xuchen Zhou, M.D.
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Dalian Medical University
Zhenyu Yang, M.D.
Role: STUDY_DIRECTOR
Wuxi People's Hospital
Yuehui Yin, M.D.
Role: STUDY_DIRECTOR
The Second Affiliated Hospital of Chongqing Medical University
Chunlai Zeng, M.D.
Role: STUDY_DIRECTOR
The Central Hospital of Lishui City
Kejun Huang, M.D.
Role: STUDY_DIRECTOR
Henan Provincial Chest Hospital
Locations
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Zhongshan Hospital
Shanghai, , China
Countries
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Other Identifiers
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PIONEER-II, OPC, P02
Identifier Type: -
Identifier Source: org_study_id
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