Clinical trial NCT02698839: A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)
Official title: A Prospective, Multicenter Trial Program in China to Evaluate the Efficacy and Safety of BuMA Supreme (eG Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Patients With de Novo Coronary Lesions, RCT Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Drug eluting stents
Interventional Cardiology
Lead sponsor: Sino Medical Sciences Technology Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-75, male or non-pregnant female
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:

1. Acute MI within 1 week
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

Primary outcomes:
measure: in-stent Late Lumen Loss, 9M
timeFrame: QCA at 9-month follow-up window
Secondary outcomes:
measure: Stent implantation success rate
timeFrame: 5 years after PCI
measure: Binary restenosis rate
timeFrame: 9 months
measure: in-segment LLL
timeFrame: 9 months
measure: diameter stenosis degree
timeFrame: 9 months
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 1, 6, 12 month, and annually up to 5 years post procedure
measure: Patient-oriented Composite Endpoint (PoCE)
timeFrame: 1, 6, 12 month, and annually up to 5 years post procedure
measure: Academic Research Consortium(ARC) defined stent thrombosis
timeFrame: 5 years after PCI
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Junbo Ge, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Yundai Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shubin Qiao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital
name: Shaoping Nie, M.D.
role: STUDY_DIRECTOR
affiliation: Shanghai 10th People's Hospital
name: Yawei Xu, M.D.
role: STUDY_DIRECTOR
affiliation: Jiangsu Proving Hospital
name: Xiangqing Kong, M.D.
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Lang Li, M.D.
role: STUDY_DIRECTOR
affiliation: Central South University
name: Xiangqian Shen, M.D.
role: STUDY_DIRECTOR
affiliation: Daqing oilfield general hospital
name: Hui Li, M.D.
role: STUDY_DIRECTOR
affiliation: Shanghai Chest Hospital
name: Linghong Shen, M.D.
role: STUDY_DIRECTOR
affiliation: Wuhan Asia Heart Hospital
name: Xi Su, M.D.
role: STUDY_DIRECTOR
affiliation: Guangdong Provincial People's Hospital
name: Jiyan Chen, M.D.
role: STUDY_DIRECTOR
affiliation: Zhongda Hospital
name: Genshang Ma, M.D.
role: STUDY_DIRECTOR
affiliation: Second Affiliated Hospital of Nanchang University
name: Xiaoshu Cheng, M.D.
role: STUDY_DIRECTOR
affiliation: Run Run Shaw Hospital
name: Guosheng Fu, M.D.
role: STUDY_DIRECTOR
affiliation: Cangzhou Central Hospital
name: Zesheng Xu, M.D.
role: STUDY_DIRECTOR
affiliation: The Second Affiliated Hospital of Zhejiang University School of Medical College
name: Jianan Wang, M.D.
role: STUDY_DIRECTOR
affiliation: The Affiliated Hospital of Qingdao University
name: Haichu Yu, M.D.
role: STUDY_DIRECTOR
affiliation: Jiangxi Provincial People's Hopital
name: Guotai Sheng, M.D.
role: STUDY_DIRECTOR
affiliation: Shengjing Hospital
name: Xiandong Li, M.D.
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Soochow University
name: Tingbo Jiang, M.D.
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Kui Chen, M.D.
role: STUDY_DIRECTOR
affiliation: West China Hospital
name: Hua Wang, M.D.
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Nanchang University
name: Menghong Wang, M.D.
role: STUDY_DIRECTOR
affiliation: Hua Mei Hospital, University of Chinese Academy of Sciences(Ningbo No.2 Hospital)
name: Honghua Ye, M.D.
role: STUDY_DIRECTOR
affiliation: Jinan Central Hospital
name: Guohai Su, M.D.
role: STUDY_DIRECTOR
affiliation: Wuhan Central Hospital
name: Manhua Chen, M.D.
role: STUDY_DIRECTOR
affiliation: The Second Hospital of Hebei Medical University
name: Yongjun Li, M.D.
role: STUDY_DIRECTOR
References: