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CAlcified Coronary Lesions Identification & Quantification With X Rays
Sponsor: RCF@ICPS
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-11-14
Completion Date
2027-02-14
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (3)
Hôpital Privé d'Antony, Institut Cardiovasculaire Paris Sud
Antony, France
Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud
Massy, France
Hôpital Privé Claude Galien, Institut Cardiovasculaire Paris Sud
Quincy-sous-Sénart, France