Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion

Starting soon · Not applicable

Conditions studied: Coronary Arteries Disease, Chronic Coronary Syndrome, Acute Coronary Syndromes (ACS), Myocardial Ischemia, Percutaneous Coronary Intervention, Coronary Computed Tomography Angiography

In brief

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.

Key facts

Study ID

NCT07592312

Run by

University of Galway

People needed

200

Starts

2026-05-18

Expected to finish

2028-12-30

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Presence of at least one target coronary lesion meeting one of the following CCTA criteria:
• Severe coronary diameter stenosis (70-99%) in one or more coronary arteries according to CAD-RADS 4A or 4B classification and at least one of the following:
• CT-derived fractional flow reserve (CT-FFR) ≤0.80
• At least 2 high-risk plaque characteristics, including:
• Low attenuation plaque density <30 Hounsfield units
• Positive remodeling index >1.1
• Napkin-ring sign
• Spotty calcification
• Left main coronary artery stenosis ≥50%
• Ostial or proximal left anterior descending artery, dominant left circumflex artery, or dominant right coronary artery stenosis ≥50% and at least one of the following:
• CT-FFR ≤0.80
• At least 2 high-risk plaque characteristics, including:
• Low attenuation plaque density <30 Hounsfield units
• Positive remodeling index >1.1
• Napkin-ring sign
• Spotty calcification
• Planned clinically indicated invasive coronary angiography with operator decision to proceed with PCI

You may not qualify if…

• 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
• Operator decision to treat a vessel not identified as a target vessel by the CCTA core laboratory analysis
• Pregnancy or breastfeeding
• Patients referred for coronary artery bypass graft surgery after invasive coronary angiography
• Participation in another investigational drug or drug-coated device study
• Inability to provide informed consent

Full record on ClinicalTrials.gov

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