BIOTRONIK Orsiro Pre-Marketing Registration

Summary

The clinical investigation is a non-inferiority, multicenter, blinding evaluation, randomized, parallel controlled clinical study enrolling up to 440 subjects. All subjects will be randomized 1:1 to receive the BIOTRONIK Orsiro SES or the Abbott Xience Prime™ EES, in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment of coronary artery disease.

Conditions

• Coronary Artery Disease

Interventions

DEVICE

Coronary Stent

Sponsors & Collaborators

• Biotronik (Beijing) Medical Device Ltd.

  lead INDUSTRY

Principal Investigators

• Yuejin Yang · Chinese Academy of Medical Sciences, Fuwai Hospital

• Jing Xu · Tianjin Chest Hospital

• Jian Zhang · TEDA International Cardiovascular Hospital

• Yaling Han · General Hospital of Shenyang Military Region

• Bo Yu · The Second Affiliated Hospital of Harbin Medical University

• Dan Song · Wuhan Asian Heart Hospital

• Wen Xie · Teaching Hospital of Chengdu University of T.C.M.

• Hui Li · Daqing oilfield general hospital

• Ye Zhu · West China Hospital

• Guosheng Fu · Sir Run Run Shaw Hospital

• Biao Xu · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

2015-07-14

Primary Completion

2017-04-06

Completion

2021-12-31

Countries

• China

Study Locations