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AzTrials

Coronary Artery CalcificationCALIPSONCT05301218

CAlcified Lesion Intervention Planning Steered by OCT.

A study testing angioplasty in people with Coronary Artery Calcification and Angioplasty, run by Institut Mutualiste Montsouris at 14 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging. Calcified lesions are very frequent among coronary artery disease stenotic lesions. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Coronary Artery Calcification, Angioplasty
What is being tested?
angioplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
14 sitesFrance
Study dates
15 Dec 2021to 15 Dec 2023
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with chronic coronary syndrome
  • Angiographically moderately to severely calcified target lesion, defined as follows:
  • Moderate: lesion with radio-opacities noted only during the cardiac cycle before contrast dye injection (Aksoy et al., Circ Cardiovasc Interv 2019)
  • Severe: lesion with radio-opacities seen without cardiac motion before contrast dye injection, visible on both sides of the arterial lumen(Aksoy et al., Circ Cardiovasc Interv 2019)
  • Possibility to cross the target lesion with OCT catheter

Who cannot join

  • On-going cardiogenic shock
  • Acute coronary syndrome related to target lesion
  • Severe renal failure (Creatinine clearance: 30 ml/min/m2)
  • Impossibility to cross target lesion with OCT catheter \& balloons,
  • Indication for Rotablator device as first line therapy
  • Pregnancy
  • Age < 18 y
  • Denial to provide consent

Trial locations and contacts

14 sites in 1 country.

Nicolas Amabile, MD PhD contact

0156616983 ext. 33

nicolas.amabile@imm.fr

Silvia Burbassi, PhD contact

0156616983 ext. 33

silvia.burbassi@imm.fr

14 sites in 1 country

France14 sites, 14 recruiting

  • Ch de Bastia

    Bastia, 20600

    Ziad Boueri, MD

    Recruiting

  • CHU de Besançon

    Besançon, 25000

    Nicolas Meneveau, MD

    Recruiting

  • CHU de Bordeaux

    Bordeaux, 33000

    Benjamin Séguy, MD

    Recruiting

  • Clinique Saint Augustin

    Bordeaux, 33200

    Frederic Casassus, MD

    Recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

    Géraud SOUTEYRAND, MD

    Recruiting

  • Hôpital Louis Pasteur

    Le Coudray, 28630

    Grégoire RANGé Rangé, MD

    Recruiting

  • L'Hôpital Privé du Confluent

    Nantes, 44000

    Erwan BRESSOLLETTE, MD

    Recruiting

  • CHU Nîmes

    Nîmes, 30029

    Guillaume Cayla, MD

    Recruiting

  • Polyclinique les Fleurs

    Ollioules, 83190

    Philippe Commeau, MD

    Recruiting

  • Institut Mutualiste montsouris

    Paris, Île-de-France Region, 75014

    Silvia Burbassi, PhD, 0156616983 ext. 33, silvia.burbassi@imm.fr

    Nicolas Amabile, MD PhD

    Recruiting

  • CHU de Poitiers

    Poitiers, 86000

    Sébastien Levesque, MD

    Recruiting

  • Clinique Saint-Hilaire

    Rouen, 76000

    Quentin LANDOLFF, MD

    Recruiting

  • Institut Arnaud Tzanck,

    Saint-Laurent-du-Var, 06700

    Julien ADJEDJ, MD

    Recruiting

  • Clinique Pasteur

    Toulouse, 31300

    Benjamin HONTON, MD

    Recruiting

Other trials in France

About this study

Calcified lesions are very frequent among coronary artery disease stenotic lesions.

The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.

Read more

Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.

The presence of calcifications increases the risk of adverse evolution after PCI , including stent restenosis, thrombosis and need for repeat revascularisation. Specific and appropriate tools can be used for calcified lesions management , including high pressure non compliant balloons, intravascular lithotripsy and rotablator. Intra vascular OCT has a high sensitivity and specificity for calcium detection among coronary artery lesions. Compared to IVUS, OCT allows a better quantification of calcium sheets (depth extension ) . Several intra coronary imaging based calcified lesions management algorithms have been proposed , but none have been validated in clinical practice.

Being tested
angioplasty
Keywords
Optical Coherence Tomography, OCT, minimal stent area(MSA)
Medical subject headings
Ornithine Carbamoyltransferase Deficiency Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • angioplastyProcedure or surgery

    Coronary angioplasty, also called percutaneous coronary intervention, is a procedure used to open clogged heart arteries. Angioplasty uses a tiny balloon catheter that is inserted in a blocked blood vessel to help widen it and improve blood flow to the heart

Study groups in NCT05301218
Study groupRoleWhat they receive
angiography-guided groupActive comparatorthe treatment (including lesion preparation, stent sizing and post implantation optimization) will be performed by angiography. Once the result is considered optimal by the operator, a control OCT run will be acquired.
Receives: Procedure: angioplasty
OCT-guided groupExperimentala preliminary OCT run will be recorded. An initial predilation with 1.5 to 2.0 mm balloon could be accepted in order to facilitate OCT catheter delivery through the target lesion. The PCI strategy will be guided by a pre-defined algorithm based on initial OCT findings. Post PCI result will be assessed by control OCT and potential optimization steps could be applied according to the results. The MLD-MAX optimization approach will be applied. Final OCT run will be performed at the end of the procedure.
Receives: Procedure: angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run

    The crude minimal stent area (MSA) will be measured along the stent on the target lesion. Stent geometric expansion will be evaluated by the DOCTORS criteria for non-bifurcated segments (Meneveau et, Circulation 2016) and LEMON criteria for bifurcated segments (Amabile et al;, Eurointervention 2020).

    Measured: During the procedure

Secondary outcomes (9)

  1. Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria

    After the stent is deployed, the blood flow dynamics influence the mechanics by compressing and expanding the structure.

    Measured: during procedure

  2. Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods)

    Qualitative Comparative Analysis (QCA) is a methodology that enables the analysis of multiple cases in complex situations

    Measured: during procedure

  3. Residual major struts malapposition: crude incidence and quantification

    malapposition was defined as a lack of contact of at least 1 strut with the underlying vessel wall (at least 150 μm, in the absence of a side branch) with evidence of blood flow behind the strut. It was classified as "major" malapposition if there was evidence of at least 30% of the struts in one frame.

    Measured: during procedure

  4. Major adverse cardiovascular events at 30 days and 1 year

    Cardiovascular death + Any myocardial infarction + need for re-intervention on the target lesion (TLR)

    Measured: at 30 days and 1 year

  5. Peri-procedural MI according to the SCAI definition (23)

    according to the SCAI definition (Moussa et al., Journal of the American College of Cardiology 2013)

    Measured: during procedure

  6. Coronary artery perforation: incidence

    Coronary perforation was defined as evidence of extravasation of dye or blood from the coronary artery during or following the interventional procedure

    Measured: during the procedure and During the full participation period (1 year).]

  7. Radiation dose

    Differences in dose radiation used during le procedure

    Measured: during procedure

  8. Total Contrast medium volume

    Differences in amount of contrast drug used during le procedure

    Measured: during procedure

  9. Procedure duration

    differences in duration (time) of the procedure

    Measured: 24th post-operative hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2022
  2. Study start15 Dec 2021
  3. Primary completion15 Dec 2023 (estimated)
  4. Study completion15 Dec 2023 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05301218
Sponsor's protocol ID
CARDIO 04 2021
Acronym
CALIPSO
Status last verified
Apr 2022
First submitted
8 Mar 2022
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Amabile N, Range G, Landolff Q, Bressollette E, Meneveau N, Lattuca B, Levesque S, Boueri Z, Adjedj J, Casassus F, Belfekih A, Veugeois A, Souteyrand G, Honton B. OCT vs Angiography for Guidance of Percutaneous Coronary Intervention of Calcified Lesions: The CALIPSO Randomized Clinical Trial. JAMA Cardiol. 2025 Jul 1;10(7):666-675. doi: 10.1001/jamacardio.2025.0741.

    PubMed 40305015

Questions about this trial

What is this clinical trial studying?

A study testing angioplasty in people with Coronary Artery Calcification and Angioplasty, run by Institut Mutualiste Montsouris at 14 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicolas Amabile, MD PhD (0156616983 ext. 33, nicolas.amabile@imm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run (time frame: During the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05301218, which also lists 1 linked publication.

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 15 Nov 2022.

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