CAlcified Coronary Lesions Identification & Quantification With X Rays (CALIQX)

June 11, 2026 updated by: RCF@ICPS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Antony, France, 92160
        • Hôpital Privé d'Antony, Institut Cardiovasculaire Paris Sud
      • Massy, France, 91300
        • Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud
      • Quincy-sous-Sénart, France, 91480
        • Hôpital Privé Claude Galien, Institut Cardiovasculaire Paris Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IVUS and 3DStent
Device: Imaging by IVUS and 3D Stent

3DStent imaging will be performed using 200° rotational angiography at 30 frames per second with a C-arm rotation speed of 10°/sec, with a deflated angioplasty balloon present within the target lesion (pre-angioplasty) or the implanted stent (post-angioplasty).

IVUS imaging will be performed using an Opticross™ catheter on an Avvigo+™ system (Boston Scientific, USA) with a withdrawal speed of 1 mm/s and intracoronary injection of 0.5 to 1 mg of nitrates.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radial extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in degrees (°).
Time Frame: Day 1
To assess one of the components of the baseline calcium burden of the plaque by measuring its length by comparing 3DS measurement and IVUS measurement
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Longitudinal extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in millimeters (mm)
Time Frame: Day 1
To assess one of the components of the baseline calcium burden of the plaque by measuring its length by comparing 3DS measurement and IVUS measurement
Day 1
Maximum calcification thickness at baseline/ before stent implantation measured by 3DStent (post-procedure), expressed in micrometers (µm)
Time Frame: Day 1
To assess one of the components of the baseline calcium burden of the plaque by measuring its maximal thickness by 3DS measurement
Day 1
Minimum intra-stent area post procedural , measured by 3DStent and IVUS, expressed in square millimeters (mm²).
Time Frame: Day 1
To assess the quality of the stent expansion following PCI by measuring its minimal area, comparing IVUS measurement and 3DS measurement
Day 1
Procedural radiation dose post procedural in milliGray (mGy)
Time Frame: Day 1
To assess impact of repeated 3DStent analyses on global patient irradiation by checking the procedure radiation dose
Day 1
Procedural mean contrast volume in milliliters (ml)
Time Frame: Day 1
To assess impact of repeated 3DStent analyses on the dose of contrast medium delivered to the patient during procedure by checking the amount of contrast used.
Day 1
Procedure duration, expressed in minutes (mins)
Time Frame: Day 1
To assess impact of repeated 3DStent analyses on procedure duration
Day 1
Adverse cardiovascular event (cardiovascular death + stent thrombosis + myocardial infarction + need for target vessel revascularization) at 30 days post-angioplasty in percent of the study population
Time Frame: Day 30
To assess safety of 3DStent analysis by checking the apparition of Major Adverse Cardiac Event (MACE) after 30 days
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RCF@ICPS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas AMABILE, MD, RCF@ICPS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25.02590.000383

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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