Heart stent study tracks outcomes in over 2,000 chinese patients
NCT ID NCT03273023
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
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Jan 2018
- Finished
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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
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Other studies related to the condition(s) this trial covers.
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