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

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: Recruiting
• Conditions: Coronary Calcification
• Intervention / Treatment: Device: Imaging by IVUS and 3D Stent

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas AMABILE, MD; Phone Number: +33160134602; Email: n.amabile@icps.com.fr
• Study Contact Backup: Name: Julia CARADO; Email: j.carado@icps.com.fr

Study Locations

• France
  • Antony, France, 92160
    • Recruiting
    • Hôpital Privé d'Antony, Institut Cardiovasculaire Paris Sud
    • Contact: Nicolas AMABILE, MD; Phone Number: +33146742375; Email: n.amabile@icps.com.fr
  • Massy, France, 91300
    • Recruiting
    • Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud
    • Contact: Hakim BENAMER, MD; Phone Number: +33160134602; Email: h.benamer@angio-icps.com
  • Quincy-sous-Sénart, France, 91480
    • Recruiting
    • Hôpital Privé Claude Galien, Institut Cardiovasculaire Paris Sud
    • Contact: Stéphane CHAMPAGNE, MD; Phone Number: +33169399169; Email: s.champagne@angio-icps.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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 (°).	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

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)	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)	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).	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)	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)	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)	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	To assess safety of 3DStent analysis by checking the apparition of Major Adverse Cardiac Event (MACE) after 30 days	Day 30

Collaborators and Investigators

• Sponsor: RCF@ICPS
• Investigators: Principal Investigator: Nicolas AMABILE, MD, RCF@ICPS

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2025
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): February 14, 2027

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID 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