Overview
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.
Eligibility
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
