Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion (NCT07592312) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion
200 participantsStarted 2026-05-18
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 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:
* 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
Exclusion Criteria:
* Contraindication to iodinated contrast media, including severe allergy or contrast-induced nephropathy
* Poor-quality or non-diagnostic CCTA imaging
* Target lesio…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Radiation dose during PCI
Timeframe: During index PCI procedure
2
Procedural time
Timeframe: During index PCI procedure
3
Contrast volume used during PCI
Timeframe: During index PCI procedure
4
Deviation rate from CCTA-based virtual PCI planning