A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)
NCT ID: NCT02698839
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
539 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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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BuMA Supreme group
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 Supreme
Stent platform: cobalt-chromium alloy
BuMA™ group
This group contains 220 subjects.
BuMA™
Stent platform: stainless steel
Interventions
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BuMA Supreme
Stent platform: cobalt-chromium alloy
BuMA™
Stent platform: stainless steel
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
Yundai Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Shubin Qiao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai 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
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 Sheng, M.D.
Role: STUDY_DIRECTOR
Jiangxi Provincial People's Hopital
Xiandong Li, M.D.
Role: STUDY_DIRECTOR
Shengjing Hospital
Tingbo Jiang, M.D.
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Soochow University
Kui Chen, M.D.
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Zhengzhou University
Hua Wang, M.D.
Role: STUDY_DIRECTOR
West China Hospital
Menghong Wang, M.D.
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Nanchang University
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
Manhua Chen, M.D.
Role: STUDY_DIRECTOR
Wuhan Central Hospital
Yongjun Li, M.D.
Role: STUDY_DIRECTOR
The Second Hospital of Hebei Medical University
Locations
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Zhongshan Hospital
Shanghai, , China
Countries
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Other Identifiers
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PIONEER-II, RCT, P01
Identifier Type: -
Identifier Source: org_study_id
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