Clinical Trial

CAlcified Coronary Lesions Identification & Quantification With X Rays

Study acronym: CALIQX
Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial completed 2026-06-13
notable Primary completion moved earlier: 2026-09-14 -> 2026-05-07 2026-06-13
minor Completion moved earlier: 2027-02-14 -> 2026-05-07 2026-06-13
Trial Details
NCT Number NCT07417150
Lead Sponsor RCF@ICPS
Conditions Coronary Calcification
Enrollment 30 participants
Start Date 2025-11-14
Primary Completion 2026-05-07 (estimated)
Study Completion 2026-05-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-12