PROMUS PREMIER™ China Post-Approval Study

An observational study of Coronary Artery Disease, run by Boston Scientific Corporation at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Type of treatment: Medical device
How many people: 2,059 participants
Where: 1 siteChina
Study dates: 11 Jan 2018to 3 Oct 2025
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang

Other trials in China

About this study

Official title: 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.

Read the 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

Conditions: Coronary Artery Disease
Being tested: Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent SystemDevice
Promus PREMIERTM Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 months

Secondary outcomes (3)

12-month Cardiac Death
Participants occurred cardiac death event in 12 months
Measured: 12 months
12-month Myocardial Infarction
Participants occurred myocardial infarction event in 12 months
Measured: 12 months
12-month TVR
Participants occurred TVR event in 12 months
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 20183 Oct 2025

First posted6 Sep 2017
Study start11 Jan 2018
Primary completion28 Dec 2020
Study completion3 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 2,059 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT03273023
Sponsor's protocol ID: S2384
Status last verified: Jul 2026
First submitted: 4 Sep 2017
Last updated: 22 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Approval Study of the PROMUS PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China
ClinicalTrials.gov ID: NCT03273023
Acronym / sponsor ID: S2384
Conditions: Coronary Artery Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 2,059 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 11 Jan 2018 (actual)
Primary completion: 28 Dec 2020 (actual)
Study completion: 3 Oct 2025 (actual)
First posted: 6 Sep 2017 (actual)
Results: Posted 22 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 5 Years

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent SystemPromus PREMIERTM Stent System	Device	–

Primary outcome

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).

3 secondary outcomes

12-month Cardiac Death
Time frame: 12 months
12-month Myocardial Infarction
Time frame: 12 months
12-month TVR
Time frame: 12 months

Results and safety

Results posted to the registry on 22 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PROMUS PREMIER Group	2,059	2,059

Primary outcome: 12-month Major Adverse Cardiac Event (MACE) Rate

Time frame: 12 months. Count of participants. Unit: Participants

Measure	PROMUS PREMIER Group n = 2059
Value	41

Population analysed: For the ITT analysis, all subjects who sign the written ICF and are enrolled in the study will be included in the analysis sample, regardless of whether the study stent was implanted.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 years. Other adverse events reported at 2.8% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PROMUS PREMIER Group	48 of 2,059 (2.3%)	58 of 2,059 (2.8%)	30 of 2,059

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Coronary Artery Disease

Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bo Yu, Dr. principal investigator

The Second Affiliated Hospital of Harbin Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Boston Scientific Corporation at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month Major Adverse Cardiac Event (MACE) Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03273023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.