The goal of this clinical trial is to learn whether coronary CT angiography (CCTA)-guided planning improves the efficiency and outcomes of percutaneous coronary intervention (PCI) in adults with coronary artery disease. It will also evaluate the feasibility and safety of using a CT-based "virtual PCI plan" during coronary interventions.
The main questions it aims to answer are:
* Does CCTA-guided PCI reduce procedural time, radiation exposure, and contrast dye use compared with standard PCI? * Does CCTA-guided PCI improve procedural outcomes and stent optimization? * How often do operators follow or deviate from the CT-based procedural plan? * What medical problems or complications occur during and after CCTA-guided PCI?
Researchers will compare CCTA-guided PCI with standard angiography-guided PCI to determine whether CT-derived procedural planning improves PCI efficiency and clinical outcomes.
Participants will:
* Undergo PCI guided either by a CCTA-based virtual planning strategy or by standard clinical practice * Attend follow-up assessments at 1 month, 6 months, and 1 year * Undergo routine clinical evaluations and imaging assessments related to their PCI procedure * Be monitored for procedural complications, symptoms, repeat procedures, and cardiovascular outcomes during follow-up
The study will also include a parallel observational registry for patients whose coronary lesions are deferred from PCI, to evaluate their long-term clinical outcomes.
Adults aged 18 to 80 years
Ability to provide written informed consent
Patients undergoing coronary computed tomography angiography (CCTA) for suspected coronary artery disease or for diagnostic work-up of stabilized acute coronary syndrome
CT-derived fractional flow reserve (CT-FFR) ≤0.80
Contraindication to iodinated contrast media, including severe allergy or contrast-induced nephropathy
Poor-quality or non-diagnostic CCTA imaging
Target lesions involving in-stent restenosis
Chronic total occlusion target lesions
Parallel
CCTA-Guided Percutaneous Coronary Intervention
Procedure/SurgeryParticipants undergo percutaneous coronary intervention (PCI) guided by a structured coronary computed tomography angiography (CCTA)-based virtual procedural planning workflow. Pre-procedural centralized CCTA analysis provides information regarding lesion morphology, vessel dimensions, lesion length, calcium burden, bifurcation anatomy, optimal angiographic projections, and CT-derived fractional flow reserve to support procedural planning and PCI optimization.
Standard Percutaneous Coronary Intervention
Procedure/SurgeryParticipants undergo PCI according to standard clinical practice and operator discretion without access to the advanced CCTA-derived virtual procedural planning. Operators may use intravascular imaging, physiological assessment, and adjunctive devices according to routine practice and guideline-based care.
Radiation dose during PCI
Radiation exposure during the invasive PCI procedure will be compared between the CCTA-guided PCI group and the standard PCI group. Radiation exposure will be quantified using dose-area product (DAP) or cumulative radiation dose recorded during the procedure.
Procedural time
Procedural time will be compared between the CCTA-guided PCI and standard PCI groups. Procedural time is defined as the interval between initial insertion of the guiding catheter into the arterial sheath and the final angiographic image.
Contrast volume used during PCI
Contrast volume used during the invasive PCI procedure will be compared between study groups. Contrast volume will be measured in millilitres and used to assess the impact of CCTA-guided planning on contrast utilization compared with standard PCI.
Deviation rate from CCTA-based virtual PCI planning
Feasibility will be assessed by recording the absolute number of deviations and relative deviation rate from the recommended CCTA-based virtual PCI planning steps. Deviations may include technical issues, clinically justified operator decisions, or unjustified deviations from the recommended plan. An overall deviation rate exceeding 10% will be considered clinically relevant.
Agreement between CCTA-based virtual PCI planning and operator standard planning
Degree of agreement between the PCI virtual planning based on CCTA and the operator's standard procedural planning, assessed in the control arm only.
Vessel-Oriented Procedural Outcome
Composite procedural endpoint including freedom from angiographic complications, final QFR greater than 0.91, successful delivery and deployment of the assigned stent, successful device withdrawal, and residual stenosis less than 20% within the implanted drug-eluting stent.
Final minimal stent diameter
Final minimal stent diameter after PCI, assessed by core laboratory quantitative coronary angiography.
Degree of functional revascularization
Degree of functional revascularization assessed by post-PCI quantitative flow ratio values for each treated vessel and compared between the CCTA-guided PCI and standard PCI groups.
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