A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)

NCT02698852 | Active Not Recruiting DMC

• 1 other identifier: PIONEER-II, OPC, P02
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Drug eluting stents; Interventional Cardiology

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Stent implantation success rate

  5 years after PCI

• Device-oriented Composite Endpoint(DoCE)

  1, 6, 12 month, and annually up to 5 years post procedure

• Patient-oriented Composite Endpoint (PoCE)

  1, 6, 12 month, and annually up to 5 years post procedure

• Academic Research Consortium(ARC) defined stent thrombosis

  5 years after PCI

Study Arms (1)

BuMA Supreme group

EXPERIMENTAL

Totally 1000 subjects combined the 220 subjects from randomized controlled trial(RCT) group

Device: BuMA Supreme

Interventions

BuMA Supreme DEVICE

Stent platform: cobalt-chromium alloy

BuMA Supreme group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75, male or non-pregnant female
• Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI
• Target lesion is primary and de-novo coronary artery disease
• The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated)
• Lesion diameter stenosis ≥70% (visually estimated)
• For each target lesion, same stent implantation only
• Acceptable candidate for Coronary Artery Bypass Grafting(CABG)
• 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

You may not qualify if:

• Acute MI within 1 week
• Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion
• More than 3 stents required
• Patients refuse to be implanted stent
• Calcified lesion failed in pre-dilation, twisted lesion and lesion unsuitable for stent delivery and expansion
• In-stent restenosis
• Planned percutaneous coronary intervention (PCI) within 3 months post procedure
• Other stents implanted within 1 year
• Severe heart failure (NYHA above III) or left ventricle ejection fraction(EF) \<40%
• Renal function damage, blood creatinine \> 176.82 μmol/L
• Bleeding tendency, active peptic ulcer disease, cerebral or subarachnoid hemorrhage, cerebral apoplexy within half year and contraindication for any anti-platelet or anticoagulation agents
• Allergic to drugs or agents used in stent or protocol (PLGA, sirolimus, aspirin, clopidogrel, contrast agent, cobalt, nickel, chromium, iron, wolfram et. al.)
• Life expectation \< 12 months
• Have not reached the primary end point when participating in other trial
• Poor compliance to the protocol

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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 oilfield general hospital

  STUDY DIRECTOR

• Linghong Shen, M.D.

  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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: March 4, 2016
• Study Start: December 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)