Measuring calcified coronary artery lesions with a 3D X-ray tool and IVUS.

CAlcified Coronary Lesions Identification & Quantification With X Rays

This test will see if a 3D Stent X-ray tool measures coronary artery calcium as accurately as intracoronary IVUS in adults with calcified coronary lesions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rcf@icps (Academic / other)
• Locations: 3 sites (Antony and 2 other locations)
• Trial ID: NCT07417150 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, non-randomized pilot comparison between a 3D Stent X-ray software tool and intracoronary intravascular ultrasound (IVUS) for quantifying native coronary calcifications. Participants are adults with angiographically visible calcified culprit coronary lesions who can be traversed with an IVUS catheter. The device used is CE-marked but applied off-label for this specific quantification purpose and the protocol follows relevant EU/MDR classification guidance. The primary approach is head-to-head imaging comparison at several private cardiovascular centers in the Paris region.

Who should consider this trial

Good fit: Adults (18+) with an angiographically calcified coronary culprit lesion that can be crossed by an IVUS catheter, able to give informed consent and affiliated with a social security scheme are ideal candidates.

Not a fit: Patients with ST-elevation myocardial infarction, progressive cardiogenic shock, lesions that cannot be traversed by an IVUS catheter, pregnant or breastfeeding women, or legally incapacitated adults are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the 3D Stent X-ray tool could offer a quicker, widely available way to quantify coronary calcium during angiography and help guide interventional planning.

How similar studies have performed: IVUS is an established method for intracoronary calcium measurement, while X‑ray–based 3D reconstruction approaches are newer and supported mainly by limited pilot comparisons rather than large definitive trials.

Eligibility criteria

Inclusion Criteria:

* Male or female aged 18 years or older
* Patient with a coronary lesion.
* Angiographically calcified culprit lesion (Mintz classification) 1 Moderate: lesion with radiopaqueness noted only during the cardiac cycle before contrast injection Severe: lesion with radiopaqueness seen without cardiac motion before contrast injection, visible on both sides of the arterial lumen
* Ability to traverse the culprit lesion with an IVUS catheter
* Having been informed by an investigator about the research topic and having given their free, explicit, and informed consent.
* Affiliation with a social security scheme (beneficiary or dependent)

Exclusion Criteria:

* Acute coronary syndrome of the ST-segment elevation myocardial infarction type
* Progressive cardiogenic shock
* Culprit lesion impassable with an IV catheter
* Pregnant, parturient, or breastfeeding women and other vulnerable categories: legally incapacitated adults, adults unable to express their consent and not subject to a protective measure, persons deprived of their liberty
* BMI \> 35 kg/m²

Where this trial is running

Antony and 2 other locations

• Hôpital Privé d'Antony, Institut Cardiovasculaire Paris Sud — Antony, France (Recruiting)
• Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud — Massy, France (Recruiting)
• Hôpital Privé Claude Galien, Institut Cardiovasculaire Paris Sud — Quincy-sous-Sénart, France (Recruiting)

Study contacts

• Principal investigator: Nicolas AMABILE, MD — Rcf@icps
• Study coordinator: Nicolas AMABILE, MD

Conditions Coronary Calcification