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Heart stent study tracks outcomes in over 2,000 chinese patients

NCT ID NCT03273023

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study looked at how well the PROMUS PREMIER stent works in everyday medical practice in China. Over 2,000 people with coronary artery disease received the stent and were followed for 12 months to track major heart problems like heart attacks or the need for another procedure. The goal was to see if the stent performs safely and effectively outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System
What this could lead to
If successful, this study could confirm that the PROMUS PREMIER stent works well in real-world Chinese patients, supporting its continued use for treating blocked heart arteries.
What could go wrong
This is a post-approval observational study, not a randomized trial, so results may not prove the stent is better than other options. Risks include heart attack, need for repeat procedures, or stent-related complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,059 people

The number who actually took part.

Started

Jan 2018

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.