NCT03273023

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,059

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

September 4, 2017

Last Update Submit

March 29, 2026

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

    The primary endpoint is the 12-month major adverse cardiac event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)

    12-month follow up

Interventions

Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent SystemDEVICE

Promus PREMIERTM Stent System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects who are candidates for coronary artery stenting, signed the informed consent form and eligible to receive a Promus PREMIERTM Stent System will be evaluated for enrollment in this study.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bo Yu, Dr.

    The Second Affiliated Hospital of Harbin Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 6, 2017

Study Start

January 11, 2018

Primary Completion

December 28, 2020

Study Completion

October 3, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

CN(1)