CAlcified Coronary Lesions Identification & Quantification With X Rays
Phase: NA
Conditions: Coronary Calcification
Sponsor: RCF@ICPS

 
 
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CALIQX Synopsis 
 
CAlcified Coronary Lesions Identification & Quantification with X‑rays 
Version 1.6 – 23 October 2025 
ID‑CRB Number: 2024‑A02724‑43 
 
SUMMARY 
Sponsor : 
RCF@ICPS 
5 rue du Théâtre 
91300 Massy, France 
 
STUDY SUMMARY 
Study title and name 
CAlcified Coronary Lesions Identification & Quantification with X‑rays 
(Identification and Quantification of Calcified Coronary Lesions using X‑rays) 
Protocol version and date 
Version 1.6 dated 23/10/2025 
Study description 
Medical device clinical investigation – Category 4.3 
Study objective 
To compare the 3DStent tool with the currently available reference method (intravascular 
ultrasound imaging – IVUS) for the assessment and quantification of native coronary 
calcifications. 
Investigational device 
Allia IGS 5 (including 3DStent) 
Number of patients 
30 patients 
Participating centers 
- Hôpital Privé d’Antony, 92160 Antony, France 

 
 
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- Hôpital Privé Claude Galien, 91480 Quincy‑sous‑Sénart, France 
- Hôpital Privé Jacques Cartier, 91300 Massy, France 
Study duration 
1 month for each patient 
Follow‑up procedures 
Patients will be contacted by telephone to assess their clinical status, complications and 
events, and any examinations and procedures that occurred after the procedure. 
 
INCLUSION CRITERIA 
To be included, patients must meet all of the following criteria: 
• Male or female aged 18 years or older 
• Patient presenting with a coronary lesion 
• Angiographically calcified culprit lesion (Mintz classification) 
o Moderate: lesion with radiopacities visible only during the cardiac cycle 
before contrast injection 
 
o Severe: lesion with radiopacities visible without cardiac motion before 
contrast injection and visible on both sides of the arterial lumen 
• Ability to cross the culprit lesion with an IVUS catheter 
• Having been informed by an investigator about the research and having provided 
free, explicit, and informed consent 
• Affiliation to a social security system (beneficiary or entitled person) 
 
NON‑INCLUSION CRITERIA 
Patients presenting with one or more of the following criteria must not be included: 
• Acute coronary syndrome with ST‑segment elevation myocardial infarction 
• Ongoing cardiogenic shock 
• Culprit lesion not crossable with an IVUS catheter 
• Pregnant, parturient or breastfeeding women and other categories of vulnerable 
persons: protected adults, adults unable to express consent and not subject to a 
protection measure, persons deprived of liberty 
• Body mass index (BMI) > 35 kg/m² 
 

 
 
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OBJECTIVE 
To compare the assessment of native coronary calcifications using the 3DStent tool with 
IVUS assessment. 
 
PRIMARY ENDPOINT 
The primary endpoint of the study is the maximum radial extent of calcification (expressed 
in quadrants and degrees) before stent implantation, measured by 3DStent and IVUS. 
 
SECONDARY ENDPOINTS 
• Longitudinal extent of calcification before stent implantation, measured by 3DStent 
(a posteriori) and IVUS, expressed in millimeters 
• Maximum thickness of calcification, measured by 3DStent (a posteriori), expressed 
in micrometers (µm) 
• Minimal luminal area before stent implantation, measured by IVUS, expressed in 
mm² 
• Minimal in‑stent area after implantation, measured by 3DStent and IVUS, expressed 
in mm² 
• Radiation dose and mean contrast volume during the procedure, expressed in mGy 
and ml respectively 
• Procedure duration, expressed in minutes 
• Major adverse cardiovascular events (cardiovascular death + stent thrombosis + 
myocardial infarction + need for target vessel revascularization) during the 
in‑hospital period and at Day 30 post‑angioplasty 
 
BENEFITS / RISKS 
The benefits of participating in the study include improvement in the quality of angioplasty 
through the systematic use of IVUS (which is not always used during stent implantation) 
and improved evaluation of native coronary calcifications by IVUS, allowing better 
adaptation of the procedure, as well as the potential reduction of short‑ and long‑term risks 
inherent to angioplasty (thrombosis, restenosis, etc.). 
The risks induced by the protocol are considered low. Patient management remains 
identical to standard care, with all potential contraindications assessed during the 
planning of the angioplasty procedure. 

 
 
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There is a foreseeable increase in X‑ray dosimetry received by the subject related to the 
rotational angiography performed for 3DStent. This increase remains modest: each 
acquisition represents less than 10% of the maximum total dose tolerated for a radiological 
examination. 
 
CLINICAL INVESTIGATION TIMELINE 
• Total planned duration of the clinical investigation: 15 months 
• Start of inclusions: 01/11/2025 
• Inclusion period duration: 9 months 
• Planned end of inclusions: 01/08/2026 
• End of follow‑up: 01/09/2026 
• End of data collection: 01/02/2027 
Sponsor: 
RCF@ICPS 
5 rue du Théâtre 
91300 Massy, France 
 
CLINICAL INVESTIGATION FLOW CHART 
Evaluations / Procedures 
Inclusion Day 0 Follow‑up Day 30 
Patient informed consent 
X 
 
Review of inclusion/exclusion criteria (1) X 
 
Physical examination* 
X 
 
Medical history* 
X 
 
Concomitant treatments* 
X 
X 
Adverse events (2) 
X 
X 
* Procedures performed according to standard care 
(1) Inclusion and exclusion criteria must be verified before obtaining patient consent 
 
(2) Adverse events are recorded from the Day 0 consent visit until the end of the last 
follow‑up at 1 month