Actively Recruiting
CAlcified Coronary Lesions Identification & Quantification With X Rays
Led by RCF@ICPS · Updated on 2026-02-18
30
Participants Needed
3
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The CALIQX trial is a prospective, multicenter, non-randomized pilot study comparing the 3DStent and IVUS methods for quantifying native coronary calcifications. The trial falls under classification 4.3 according to the classification and evaluation process under EU Regulation 2017/745 (MDR) and national adaptation of clinical investigations concerning medical devices: CE-marked medical device (any class), used off-label without the objective of CE marking or establishing conformity. Compare the evaluation of native coronary calcifications with 3D Stent tool versus evaluation by intracoronary IVUS imaging.
CONDITIONS
Official Title
CAlcified Coronary Lesions Identification & Quantification With X Rays
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Patient with a coronary lesion
- Angiographically calcified culprit lesion classified as moderate or severe by Mintz classification
- Ability to pass an IVUS catheter through the culprit lesion
- Has been informed about the research and given free, explicit, informed consent
- Affiliated with a social security scheme (beneficiary or dependent)
You will not qualify if you...
- Acute coronary syndrome of ST-segment elevation myocardial infarction type
- Progressive cardiogenic shock
- Culprit lesion impassable with an IV catheter
- Pregnant, parturient, or breastfeeding women
- Legally incapacitated adults or adults unable to provide consent
- Persons deprived of their liberty
- Body mass index (BMI) greater than 35 kg/m²
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hôpital Privé d'Antony, Institut Cardiovasculaire Paris Sud
Antony, France, 92160
Actively Recruiting
2
Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud
Massy, France, 91300
Actively Recruiting
3
Hôpital Privé Claude Galien, Institut Cardiovasculaire Paris Sud
Quincy-sous-Sénart, France, 91480
Actively Recruiting
Research Team
N
Nicolas AMABILE, MD
CONTACT
J
Julia CARADO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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