Coronary Calcification
Conditions
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.
Interventions
DEVICEImaging 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.
Sponsors
RCF@ICPS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in degrees (°). | Day 1 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in millimeters (mm) | Day 1 | 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 |
| Maximum calcification thickness at baseline/ before stent implantation measured by 3DStent (post-procedure), expressed in micrometers (µm) | Day 1 | To assess one of the components of the baseline calcium burden of the plaque by measuring its maximal thickness by 3DS measurement |
| Minimum intra-stent area post procedural , measured by 3DStent and IVUS, expressed in square millimeters (mm²). | Day 1 | To assess the quality of the stent expansion following PCI by measuring its minimal area, comparing IVUS measurement and 3DS measurement |
| Procedural radiation dose post procedural in milliGray (mGy) | Day 1 | To assess impact of repeated 3DStent analyses on global patient irradiation by checking the procedure radiation dose |
| Procedural mean contrast volume in milliliters (ml) | Day 1 | To assess impact of repeated 3DStent analyses on the dose of contrast medium delivered to the patient during procedure by checking the amount of contrast used. |
| Procedure duration, expressed in minutes (mins) | Day 1 | To assess impact of repeated 3DStent analyses on procedure duration |
| Adverse cardiovascular event (cardiovascular death + stent thrombosis + myocardial infarction + need for target vessel revascularization) at 30 days post-angioplasty in percent of the study population | Day 30 | To assess safety of 3DStent analysis by checking the apparition of Major Adverse Cardiac Event (MACE) after 30 days |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORNicolas AMABILE, MD
RCF@ICPS
Outcome results
None listed