NCT07417150

CAlcified Coronary Lesions Identification & Quantification With X Rays

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: RCF@ICPS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-14
• Primary completion: 2026-09-14
• Completion: 2027-02-14
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

3 sites across 1 country: France