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Virtual stenting tech aims to improve heart artery procedures

NCT ID NCT07635407

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

About 1,472 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

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: * 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fuwai Hospital, CAMS & PUMC

    RECRUITING

    Beijing, Beijing Municipality, 100037, China

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