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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
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.
Hôpital Privé d'Antony, Institut Cardiovasculaire Paris Sud
Antony, France
RECRUITINGHôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud
Massy, France
RECRUITINGHôpital Privé Claude Galien, Institut Cardiovasculaire Paris Sud
Quincy-sous-Sénart, France
RECRUITINGRadial extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in degrees (°).
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
Time frame: Day 1
Longitudinal extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in millimeters (mm)
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
Time frame: Day 1
Maximum calcification thickness at baseline/ before stent implantation measured by 3DStent (post-procedure), expressed in micrometers (µm)
To assess one of the components of the baseline calcium burden of the plaque by measuring its maximal thickness by 3DS measurement
Time frame: Day 1
Minimum intra-stent area post procedural , measured by 3DStent and IVUS, expressed in square millimeters (mm²).
To assess the quality of the stent expansion following PCI by measuring its minimal area, comparing IVUS measurement and 3DS measurement
Time frame: Day 1
Procedural radiation dose post procedural in milliGray (mGy)
To assess impact of repeated 3DStent analyses on global patient irradiation by checking the procedure radiation dose
Time frame: Day 1
Procedural mean contrast volume in milliliters (ml)
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.
Time frame: Day 1
Procedure duration, expressed in minutes (mins)
To assess impact of repeated 3DStent analyses on procedure duration
Time frame: Day 1
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
To assess safety of 3DStent analysis by checking the apparition of Major Adverse Cardiac Event (MACE) after 30 days
Time frame: Day 30
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