CT-Guided heart stenting could cut procedure time and radiation
NCT ID NCT07592312
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether using a CT scan to plan a heart stent procedure (PCI) makes it faster, safer, and more effective than the usual approach. About 200 adults with coronary artery disease will either get CT-guided planning or standard care. Researchers will compare procedure time, radiation exposure, and contrast dye use, and follow participants for one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Coronary computed tomography angiography (CCTA)-guided procedural planning
- What this could lead to
- If successful, this could make coronary stenting faster, safer, and more precise by using CT scans to plan the procedure beforehand.
- What could go wrong
- This is an early-stage feasibility study with only 200 participants, so results may not apply to all patients. The CT-based plan may not always match what the doctor sees during the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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