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Completed

NCT Number: NCT07417150

CAlcified Coronary Lesions Identification & Quantification With X Rays

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.

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Key information

Conditions

Coronary Calcification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé d'Antony, Institut Cardiovasculaire Paris Sud, Antony, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imaging by IVUS and 3D Stent

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. Procedure duration, expressed in minutes (mins)

    Time frame: Day 1

    To assess impact of repeated 3DStent analyses on procedure duration

  7. 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

Sponsors and collaborators

Lead sponsor

RCF@ICPS

Other

Registry information

Acronym: CALIQX

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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