Coronary Artery Disease, Coronary Stenosis, Ischemic Heart Disease
Conditions
Keywords
Percutaneous Coronary Intervention, Quantitative Flow Ratio, Virtual Stenting, Coronary Physiology, Coronary Artery Disease, Physiological Optimization, Functional Revascularization
Brief 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.
Detailed description
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.
Interventions
PROCEDUREVirtual Stenting-Guided PCI Optimization
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.
PROCEDUREStandard Angiography-Guided PCI
Conventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological optimization.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the procedural nature of PCI, treating operators cannot be blinded to treatment allocation. Participants and clinical outcome assessors will remain blinded to treatment assignment during follow-up. Endpoint adjudication will be performed by blinded assessors.
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either coronary imaging-physiology fusion-based virtual stenting-guided preprocedural PCI optimization or standard angiography-guided PCI. Treatment assignment will remain fixed throughout study participation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | Within 1 year after PCI | Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-PCI Physiological Optimization | Immediately after PCI | 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. |
| Cardiovascular Death or Nonfatal Myocardial Infarction | Within 1 year after PCI | Composite of cardiovascular death and nonfatal myocardial infarction after index PCI. |
| Myocardial Infarction | Within 1 year after PCI | 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). |
Countries
China
Contacts
CONTACTYing Song, MD
Outcome results
None listed