QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary… (NCT07635407) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary Intervention: A Randomized Controlled Trial
China1,472 participantsStarted 2026-07-01
Plain-language summary
Coronary angiography-guided percutaneous coronary intervention (PCI) remains the standard treatment strategy for patients with coronary artery disease; however, suboptimal post-PCI physiological outcomes remain common and are associated with adverse cardiovascular prognosis. Quantitative Flow Ratio (QFR)-based virtual stenting technology enables simulation of post-intervention coronary physiology before PCI and may facilitate individualized optimization of stent implantation strategies.
This multicenter, prospective, randomized controlled trial aims to evaluate whether preprocedural physiological optimization of PCI using coronary imaging-physiology fusion-based virtual stenting technology improves clinical outcomes compared with conventional angiography-guided PCI. Eligible patients undergoing PCI for coronary artery disease will be randomized in a 1:1 ratio to either virtual stenting-guided PCI optimization or standard angiography-guided PCI.
The primary endpoint is major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization within 1 year after PCI. Secondary endpoints include post-PCI physiological optimization, cardiovascular death or nonfatal myocardial infarction, repeat revascularization, quality of life, procedural safety, and health economic outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called QFR-guided virtual stenting to plan where and how stents are placed before the procedure actually happens — can you explain how that differs from how my PCI procedure would normally be planned, and whether that approach might matter for my specific blockages?
2Since this trial is not yet recruiting, how far away do you think it realistically is from enrolling patients, and should I be making treatment decisions now rather than waiting to see if I could eventually participate?
3The trial is measuring Major Adverse Cardiovascular Events as its primary outcome — can you help me understand what kinds of events that includes, and how my current condition affects my personal risk of those events whether or not I join a trial like this?
4This trial is listed as Phase NA, which seems to apply to device or procedure-based studies rather than drug trials — does that change what we know about the safety profile of QFR-guided planning, and is there already published evidence on how it performs?
5Given that I haven't been enrolled in this trial yet and it's not even recruiting, would standard PCI guided by conventional methods be a reasonable path for me right now, or is there a reason to hold off and explore whether this kind of physiological optimization study might be a better fit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major Adverse Cardiovascular Events (MACE)
Timeframe: Within 1 year after PCI
Trial details
NCT IDNCT07635407
SponsorChina National Center for Cardiovascular Diseases