Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07417150

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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

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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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