HELIOS China Registry: Evaluation of the HELIOS Stent in a 'Real-World' Patient Population

Summary

The study aims to evaluate the safety and efficacy of biodegradable polymer sirolimus-eluting coronary stent system (HELIOS) in patients with coronary artery disease . The primary endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel related myocardial infarction and clinically-driven target lesion revascularization at 1 year follow-up.

Conditions

• Coronary Artery Disease

Interventions

DEVICE

HELIOS biodegradable polymer sirolimus-eluting stents

HELIOS biodegradable polymer sirolimus-eluting stents

Sponsors & Collaborators

• Beijing Luhe Hospital

  collaborator OTHER

• Cangzhou People's Hospital

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• First Affiliated Hospital of Shantou University Medical College

  collaborator OTHER

• Western Central Hospital of Hainan Province

  collaborator UNKNOWN

• Second Affiliated Hospital of Hainan Medical College

  collaborator UNKNOWN

• Huizhou Municipal Central Hospital

  collaborator OTHER

• First People's Hospital of Yulin

  collaborator OTHER

• Shaanxi Armed Police Corps Hospital

  collaborator UNKNOWN

• Xi'an No.3 Hospital

  collaborator OTHER_GOV

• Tang-Du Hospital

  collaborator OTHER

• Ankang Central Hospital

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Cardiovascular Hospital of Ningxia Medical University

  collaborator UNKNOWN

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Kaifeng Central Hospital

  collaborator OTHER

• Xinyang Central Hospital

  collaborator OTHER

• People's Hospital of Zhengzhou University

  collaborator OTHER

• Zhoupu Hospital, Pudong New Area, Shanghai

  collaborator UNKNOWN

• Shanghai Longhua Hospital

  collaborator UNKNOWN

• Huangshan Shoukang Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Southern Anhui Medical College

  collaborator UNKNOWN

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Harbin Medical University

  collaborator OTHER

• Third Affiliated Hospital of Qiqihar

  collaborator UNKNOWN

• First Affiliated Hospital of Jiamusi

  collaborator UNKNOWN

• Harbin First Hospital

  collaborator UNKNOWN

• The Second Hospital of Shenyang Medical College

  collaborator OTHER

• Yingkou Central Hospital

  collaborator UNKNOWN

• Xijing Hospital

  lead OTHER

Principal Investigators

• Ling Tao, MD, PhD · First Affiliated Hospital，Fourth Military Medical University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-01

Primary Completion

2021-12-01

Completion

2025-12-01

Countries

• China

Study Locations