NCT07592312Not yet recruiting
Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion
CT-PROVE: Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 7 May 2026
- Start date
- 18 May 2026
- Primary completion date
- 20 May 2028
- Lead sponsor
- University of Galway
- Diseases
- Coronary artery disease
- NCT number
- NCT07592312
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 18 May 2026 to the primary completion date, 20 May 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients referred for coronary artery bypass graft surgery after invasive coronary angiography
- Participation in another investigational drug or drug-coated device study
Other illness
- Contraindication to iodinated contrast media, including severe allergy or contrast-induced nephropathy
Lab values
- Operator decision to treat a vessel not identified as a target vessel by the CCTA core laboratory analysis
Other
- Poor-quality or non-diagnostic CCTA imaging
- Target lesions involving in-stent restenosis
- Chronic total occlusion target lesions
- Pregnancy or breastfeeding
- Inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.