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

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

Interventions

DEVICE

BuMA Supreme

Stent platform: cobalt-chromium alloy

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.

  lead INDUSTRY

Principal Investigators

• Junbo Ge, M.D. · Shanghai Zhongshan Hospital

• Shubin Qiao, M.D. · Chinese Academy of Medical Sciences, Fuwai Hospital

• Yundai Chen, M.D. · Chinese PLA General Hospital

• Shaoping Nie, M.D. · Beijing Anzhen Hospital

• Yawei Xu, M.D. · Shanghai 10th People's Hospital

• Xiangqing Kong, M.D. · Jiangsu Proving Hospital

• Lang Li, M.D. · First Affiliated Hospital of Guangxi Medical University

• Xiangqian Shen, M.D. · Central South University

• Hui Li, M.D. · Daqing oilfield general hospital

• Linghong Shen, M.D. · Shanghai Chest Hospital

• Xi Su, M.D. · Wuhan Asia Heart Hospital

• Jiyan Chen, M.D. · Guangdong Provincial People's Hospital

• Genshang Ma, M.D. · Zhongda Hospital

• Xiaoshu Cheng, M.D. · Second Affiliated Hospital of Nanchang University

• Guosheng Fu, M.D. · Run Run Shaw Hospital

• Zesheng Xu, M.D. · Cangzhou Central Hospital

• Bin Li, M.D. · Hainan General Hospital

• Jianan Wang, M.D. · The Second Affiliated Hospital of Zhejiang University School of Medical College

• Haichu Yu, M.D. · The Affiliated Hospital of Qingdao University

• Guotai Shen, M.D. · Jiangxi Provincial People's Hopital

• Xiandong Li, M.D. · Shengjing Hospital

• Xianxian Zhao, M.D. · Changhai Hospital

• Tingbo Jiang, M.D. · The First Affiliated Hospital of Soochow University

• Mingzhe Li, M.D. · Xuzhou Central Hospital

• Zheng Zhang, M.D. · LanZhou University

• Bei Shi, M.D. · Zunyi Medical College

• Jinyu Huang, M.D. · Affiliated Hangzhou First People's Hospital ,Zhengzhou University School of Medicine

• Honghua Ye, M.D. · Hua Mei Hospital, University of Chinese Academy of Sciences(Ningbo No.2 Hospital)

• Guohai Su, M.D. · Jinan Central Hospital

• Hanjun Pei, M.D. · The First Affiliated Hospital of BaoTou Medical College

• Shaobin Jia, M.D. · General Hospital of Ningxia Medical University

• Chun Liang, M.D. · Shanghai Changzheng Hospital

• Ronghai Man, M.D. · Chifeng Municipal Hospital

• Jinchuan Yan, M.D. · Affiliated Hospital of Jiangsu University

• Xuchen Zhou, M.D. · The First Affiliated Hospital of Dalian Medical University

• Zhenyu Yang, M.D. · Wuxi People's Hospital

• Yuehui Yin, M.D. · The Second Affiliated Hospital of Chongqing Medical University

• Chunlai Zeng, M.D. · The Central Hospital of Lishui City

• Kejun Huang, M.D. · Henan Provincial Chest Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2019-05-31

Completion

2025-12-31

Countries

• China

Study Locations