An interventional study of Virtual Stenting-Guided PCI Optimization and Standard Angiography-Guided PCI in Coronary Artery Disease, Coronary Stenosis and Ischemic Heart Disease, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment
Among 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases — 26 open to participants now, 27 under way, none of them phase 3. Coronary Artery Disease · China National Center for Cardiovascular Diseases.
Among the 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases, this one is the 7th largest by planned enrollment of the 32 interventional ones that give a count, is one of 11 that started in 2026, is one of 26 with no phase, reaches primary completion later than 19 of the 26 other live ones, and was the 53rd registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
Browse Coronary Artery Disease studies →26 of the 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases are open now, in 1 country. Recruiting first, the newest first:
China National Center for Cardiovascular Diseases · Sites in China
China National Center for Cardiovascular Diseases · Sites in China
China National Center for Cardiovascular Diseases · Sites in China
China National Center for Cardiovascular Diseases · Sites in China
China National Center for Cardiovascular Diseases · Sites in China
By country, each count listing its studies:
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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57 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 11 started in 2026.
This study's planned enrollment of 1,472 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Median enrollment 501 across the 32 interventional studies, 460 across the 25 observational. Of the 20 that completed or were terminated, 0 (0%) have results posted.
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China National Center for Cardiovascular Diseases is the lead sponsor of 269 studies on the registry; 141 are open to participants now.
6 of the studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05638867China National Center for Cardiovascular DiseasesNOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI | 2026-12 |
| NCT06917664China National Center for Cardiovascular DiseasesTreatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease | 2026-12 |
| NCT07660419China National Center for Cardiovascular DiseasesEffect of Mobile-Based Home Cardiac Rehabilitation on Coronary Plaque | 2026-12-31 |
| NCT06822894China National Center for Cardiovascular DiseasesClinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease | 2026-12-31 |
| NCT06932874China National Center for Cardiovascular DiseasesMetformin Hydrochloride Sustained-release Tablets (Ⅲ) in Patients With Type 2 Diabetes Mellitus Complicated With Coronary Heart Disease | 2026-12-31 |
Among the 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases, from their registry updates:
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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.
Percutaneous coronary intervention (PCI) guided by coronary angiography remains the current standard treatment approach for coronary artery disease. However, angiographic optimization does not necessarily correspond to physiological optimization, and a considerable proportion of patients experience suboptimal post-PCI coronary physiological results, which are associated with increased risks of adverse cardiovascular events.
Quantitative Flow Ratio (QFR)-derived physiological assessment provides a non-wire, angiography-based method for functional evaluation of coronary lesions. Recent developments in virtual stenting technology enable simulation of residual coronary physiology after hypothetical stent implantation, thereby allowing preprocedural prediction of post-PCI QFR and optimization of interventional strategies.
The present study is a multicenter, prospective, randomized controlled superiority trial designed to evaluate whether coronary imaging-physiology fusion-based virtual stenting technology for preprocedural physiological optimization improves clinical outcomes compared with conventional angiography-guided PCI.
Approximately 1,472 participants with coronary artery disease undergoing PCI will be randomized in a 1:1 ratio to either: Virtual stenting-guided PCI optimization; or Standard angiography-guided PCI.
The primary endpoint is 1-year major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization.
Secondary endpoints include immediate post-PCI physiological optimization, cardiovascular death or nonfatal myocardial infarction, repeat revascularization, quality of life assessed by Seattle Angina Questionnaire (SAQ) and EuroQol Five-Dimensional Questionnaire (EQ-5D), procedural safety, and health economic outcomes.
Participants will be followed at 30 days, 6 months, and 12 months after PCI. The study will also evaluate concordance between predicted post-PCI QFR derived from virtual stenting and actual postprocedural physiological measurements, as well as changes in operator treatment strategies after physiological optimization.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the experimental group will undergo coronary imaging-physiology fusion-based virtual stenting analysis before PCI. Predicted post-PCI physiological outcomes will be used to optimize interventional strategies, including lesion coverage, stent length, stent position, and procedural planning before stent implantation.
Procedure: Virtual Stenting-Guided PCI Optimization
Participants randomized to the control group will undergo PCI according to standard angiographic guidance and operator judgment without virtual stenting-guided physiological optimization.
Procedure: Standard Angiography-Guided PCI
Preprocedural physiological optimization of PCI using coronary imaging-physiology fusion-based virtual stenting technology based on angiography-derived Quantitative Flow Ratio (QFR) assessment to guide stent implantation strategy.
Conventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological optimization.
Major Adverse Cardiovascular Events (MACE)
Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI.
Time frame: Within 1 year after PCI
Post-PCI Physiological Optimization
Successful physiological optimization defined as postprocedural TIMI grade 3 flow and post-PCI Quantitative Flow Ratio (QFR) ≥0.90 in the target vessel immediately after PCI.
Time frame: Immediately after PCI
Cardiovascular Death or Nonfatal Myocardial Infarction
Composite of cardiovascular death and nonfatal myocardial infarction after index PCI.
Time frame: Within 1 year after PCI
Myocardial Infarction
This includes perioperative myocardial infarction and non-fatal myocardial infarction (including target vessel and non-target vessel related myocardial infarction) (30 days, 6 months, and 1 year postoperatively).
Time frame: Within 1 year after PCI
All-Cause Mortality
Death from any cause, including cardiovascular death, non-cardiovascular death, or death of undetermined cause.
Time frame: Within 1 year after PCI
Ischemia-Driven Repeat Revascularization
Repeat coronary revascularization (PCI or CABG) associated with ischemic symptoms, positive functional testing, angiographic stenosis ≥50% with ischemic evidence, or stenosis ≥70% regardless of symptoms.
Time frame: Within 1 year after PCI
All revascularization
Including target-vessel and non-target vessel, ischemia-driven and non-ischemia driven
Time frame: Within 1 year after PCI
Definite or Probable Stent Thrombosis
Definite or probable stent thrombosis according to ARC-2 definitions, including acute, subacute, late, and very late stent thrombosis.
Time frame: Within 1 year after PCI
Major Bleeding Events
Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.
Time frame: Within 1 year after PCI
Health-Related Quality of Life - SAQ
Quality of life assessed using the Seattle Angina Questionnaire (SAQ)
Time frame: Baseline, 6 months, and 12 months after PCI
Health-Related Quality of Life - EQ-5D
Quality of Life assessed by EuroQol Five-Dimensional Questionnaire (EQ-5D).
Time frame: Baseline, 6 months, and 12 months after PCI
Quality-Adjusted Life Years (QALYs)
Cost-utility evaluation using quality-adjusted life years estimated from EQ-5D utility scores using the Japanese time trade-off (TTO) conversion algorithm.
Time frame: Within 1 year after PCI
Healthcare Costs
Direct medical costs including index hospitalization costs, cardiovascular medication costs, outpatient costs, hospitalization costs, and MACE-related medical expenditures.
Time frame: Baseline, 1 month, 6 months, and 12 months after PCI
Plan to share: Yes — Deidentified individual participant data underlying the results reported in publications, including demographic characteristics, baseline clinical variables, procedural information, and outcome measures, may be shared upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 12 months after publication and ending 5 years after publication
Access criteria: Data will be made available to qualified researchers upon reasonable request and approval by the study steering committee, subject to institutional and regulatory requirements.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2028, 30 months after the start.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 30 months is close to that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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China National Center for Cardiovascular Diseases →