Skip to main content
OpenTrials
Completed

NCT Number: NCT03273023

PROMUS PREMIER™ China Post-Approval Study

To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical practice in China.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

About this study

Each site will be allowed to enroll up to a maximum of 300 subjects. The scheduled follow up will occur at 30 days, 6 months, 12 months and then annually through 5 years post stent implant, for all enrolled subjects. Follow-up will be conducted via telephone contact or clinic visit

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be at least 18 years of age
  • Subject understands and provides written informed consent
  • Subject who is clinically indicated and will have an attempt of at least one Promus PREMIERTM Stent OR Subject who is clinically indicated and was implanted with at least one Promus PREMIERTM Stent
  • Subject is willing to comply with all protocol-required follow-up evaluation

Exclusion criteria

  • Exclusion criteria are not required in the PE PREMIERTM China Post-Approval Study which is an "all comers" study.

Treatment and study plan

Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System

Device

Promus PREMIERTM Stent System

Primary outcomes

  1. 12-month Major Adverse Cardiac Event (MACE) Rate

    Time frame: 12 months

    12-month Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR).

Secondary outcomes

  1. 12-month Cardiac Death

    Time frame: 12 months

    Participants occurred cardiac death event in 12 months

  2. 12-month Myocardial Infarction

    Time frame: 12 months

    Participants occurred myocardial infarction event in 12 months

  3. 12-month TVR

    Time frame: 12 months

    Participants occurred TVR event in 12 months

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Post-Approval Study of the PROMUS PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Sep 6, 2017
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.