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

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.

Conditions

• Coronary Artery Disease

Interventions

DEVICE

BuMA Supreme

Stent platform: cobalt-chromium alloy

DEVICE

BuMA™

Stent platform: stainless steel

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.

  lead INDUSTRY

Principal Investigators

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

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

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

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

• Xiandong Li, M.D. · Shengjing Hospital

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

• Kui Chen, M.D. · The First Affiliated Hospital of Zhengzhou University

• Hua Wang, M.D. · West China Hospital

• Menghong Wang, M.D. · The First Affiliated Hospital of Nanchang University

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

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

• Manhua Chen, M.D. · Wuhan Central Hospital

• Yongjun Li, M.D. · The Second Hospital of Hebei Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2018-03-31

Completion

2025-12-31

Countries

• China

Study Locations