Virtual stenting tech aims to improve heart artery procedures
NCT ID NCT07635407
First seen Jun 25, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This study tests whether using a computer simulation (virtual stenting) before placing stents in heart arteries can lead to better outcomes than the usual method guided by X-ray images alone. About 1,472 adults with coronary artery disease will be randomly assigned to either the virtual stenting approach or standard care. The main goal is to see if the virtual method reduces the chance of death, heart attack, or needing another procedure within a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Virtual stenting technology (QFR-based) used to guide stent placement during PCI
- What this could lead to
- If successful, this could lead to a more precise way to place stents in heart arteries, reducing the risk of future heart attacks or repeat procedures.
- What could go wrong
- This is an early-stage trial (Phase NA) with 1472 participants, and the technology may not improve outcomes over standard care. There are also risks inherent to the PCI procedure itself.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,472 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Age ≥18 years. * Diagnosis of coronary artery disease requiring percutaneous coronary intervention (PCI) according to current clinical practice. * Presence of at least one target coronary lesion considered suitable for PCI and evaluable by angiography-derived Quantitative Flow Ratio (QFR). * Ability to undergo coronary angiography and PCI. Provision of written informed consent before study participation. Exclusion Criteria: * Contraindications to PCI or inability to undergo coronary intervention. Severe renal dysfunction or other conditions making angiographic procedures unsuitable. * High bleeding risk judged by investigators. * Inability to complete follow-up or comply with study procedures. * Life expectancy less than 1 year due to non-cardiovascular comorbidities. * Participation in another interventional clinical trial that may interfere with study outcomes. * Coronary anatomy unsuitable for QFR-based virtual stenting analysis. * Any condition judged by investigators to make study participation inappropriate.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fuwai Hospital, CAMS & PUMC
RECRUITINGBeijing, Beijing Municipality, 100037, China
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