CAlcified Coronary Lesions Identification & Quantification With X Rays

NCT07417150 | Completed

• 1 other identifier: 25.02590.000383
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Coronary Calcification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Longitudinal extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in millimeters (mm)

  Day 1

• Maximum calcification thickness at baseline/ before stent implantation measured by 3DStent (post-procedure), expressed in micrometers (µm)

  Day 1

• Minimum intra-stent area post procedural , measured by 3DStent and IVUS, expressed in square millimeters (mm²).

  Day 1

• Procedural radiation dose post procedural in milliGray (mGy)

  Day 1

• Procedural mean contrast volume in milliliters (ml)

  Day 1

Study Arms (1)

IVUS and 3DStent

EXPERIMENTAL

Device: Imaging by IVUS and 3D Stent

Interventions

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.

IVUS and 3DStent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• RCF@ICPS: lead

Study Sites (3)

Hôpital Privé d'Antony, Institut Cardiovasculaire Paris Sud

Antony, 92160, France

Location

Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud

Massy, 91300, France

Location

Hôpital Privé Claude Galien, Institut Cardiovasculaire Paris Sud

Quincy-sous-Sénart, 91480, France

Location

Study Officials

• Nicolas AMABILE, MD

  RCF@ICPS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 18, 2026
• Study Start: November 14, 2025
• Primary Completion: May 7, 2026
• Study Completion: May 7, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (3)