PROMUS PREMIER™ China Post-Approval Study

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 2059

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The Second Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month Major Adverse Cardiac Event (MACE) Rate	12-month Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month Cardiac Death	Participants occurred cardiac death event in 12 months	12 months
12-month Myocardial Infarction	Participants occurred myocardial infarction event in 12 months	12 months
12-month TVR	Participants occurred TVR event in 12 months	12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Bo Yu, Dr., The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Actual): December 28, 2020
• Study Completion (Actual): October 3, 2025

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; MTOR Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Trace Elements; Micronutrients; Everolimus; Chromium
• Other Study ID Numbers: S2384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes