Coronary CalcificationCALIQXNCT07417150
CAlcified Coronary Lesions Identification & Quantification With X Rays
A study testing Imaging by IVUS and 3D Stent in people with Coronary Calcification, run by RCF@ICPS at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Calcification
- What is being tested?
- Imaging by IVUS and 3D Stent
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Nov 2025to 7 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Privé d'Antony, Institut Cardiovasculaire Paris Sud
Antony, 92160
Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud
Massy, 91300
Hôpital Privé Claude Galien, Institut Cardiovasculaire Paris Sud
Quincy-sous-Sénart, 91480
About this study
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.
- Conditions
- Coronary Calcification
- Being tested
- Imaging by IVUS and 3D Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging by IVUS and 3D StentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| IVUS and 3DStent | Experimental | Not described Receives: Device: Imaging by IVUS and 3D Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial 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
Measured: Day 1
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 1
Procedure duration, expressed in minutes (mins)
To assess impact of repeated 3DStent analyses on procedure duration
Measured: 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
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start14 Nov 2025
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- RCF@ICPS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas AMABILE, MD, Principal investigator, RCF@ICPS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417150
- Sponsor's protocol ID
- 25.02590.000383
- Acronym
- CALIQX
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAlcified Coronary Lesions Identification & Quantification With X Rays
- ClinicalTrials.gov ID
- NCT07417150
- Acronym / sponsor ID
- CALIQX / 25.02590.000383
- Conditions
- Coronary Calcification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- RCF@ICPSUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVUS and 3DStent | Experimental | Device: Imaging by IVUS and 3D Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging by IVUS and 3D Stent3DStent 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. | Device | IVUS and 3DStent |
Primary outcome
Radial extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in degrees (°).
Time frame: 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
7 secondary outcomes
Longitudinal extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in millimeters (mm)
Time frame: Day 1
Maximum calcification thickness at baseline/ before stent implantation measured by 3DStent (post-procedure), expressed in micrometers (µm)
Time frame: Day 1
Minimum intra-stent area post procedural , measured by 3DStent and IVUS, expressed in square millimeters (mm²).
Time frame: Day 1
Procedural radiation dose post procedural in milliGray (mGy)
Time frame: Day 1
Procedural mean contrast volume in milliliters (ml)
Time frame: Day 1
Procedure duration, expressed in minutes (mins)
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
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas AMABILE, MD principal investigator
RCF@ICPS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging by IVUS and 3D Stent in people with Coronary Calcification, run by RCF@ICPS at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in degrees (°). (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.