Clinical trial Recruiting at 1 site Interventional Ages 18 and up

QFR-guided virtual stenting to optimize PCI before the procedure

Official title: A Multicenter, Prospective, Randomized Controlled Trial of Preprocedural Physiological Optimization of Percutaneous Coronary Intervention Using Coronary Imaging-Physiology Fusion-Based Virtual Stenting Technology

Run by China National Center for Cardiovascular Diseases · NCT07635407 · Data updated 2026-11-12

We’re testing whether using QFR-based virtual stenting before PCI can improve heart-procedure outcomes compared with standard angiography planning in adults with coronary artery disease.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1472 (estimated)
SponsorChina National Center for Cardiovascular Diseases
Government
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJune 2, 2026
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedJuly 6, 2026
Trial IDNCT07635407 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with coronary artery disease requiring PCI and at least one target lesion evaluable by QFR who can undergo angiography and PCI.

Probably not a fit

Patients whose anatomy or comorbidities limit the benefit of physiology-guided planning or who do not experience suboptimal post-PCI physiology may see no added advantage.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter trial compares virtual stenting-guided PCI optimization to conventional angiography-guided PCI. It uses imaging-physiology fusion to simulate post-PCI physiology and guide stent strategy before intervention. Eligible adults with coronary artery disease undergoing PCI are randomized 1:1 to receive either the virtual stenting approach or standard care. The primary endpoint is 1-year major adverse cardiovascular events. The study aims to determine if preprocedural physiological optimization can translate into better clinical outcomes.

Why it matters

Potential benefit: If successful, patients may experience fewer major adverse cardiovascular events after PCI through more precise, physiology-guided stent planning.

How similar studies have gone: Previous work in physiology-guided PCI and noninvasive QFR-based assessments suggests potential benefits, but direct preprocedural virtual stenting optimization is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Fuwai Hospital, CAMS & PUMC
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.