Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2021-12-15
2023-12-15
Brief Summary
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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. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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angiography-guided group
the 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.
angioplasty
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
OCT-guided group
a 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.
angioplasty
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
Interventions
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angioplasty
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
Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Possibility to cross the target lesion with OCT catheter
Exclusion Criteria
2. Acute coronary syndrome related to target lesion
3. Severe renal failure (Creatinine clearance: 30 ml/min/m2)
4. Impossibility to cross target lesion with OCT catheter \& balloons,
5. Indication for Rotablator device as first line therapy
6. Pregnancy
7. Age \< 18 y
8. Denial to provide consent
18 Years
100 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Institut Mutualiste Montsouris
OTHER
Responsible Party
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Principal Investigators
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Nicolas Amabile, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Mutualiste Montsouris
Locations
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Ch de Bastia
Bastia, , France
CHU de Besançon
Besançon, , France
CHU de Bordeaux
Bordeaux, , France
Clinique Saint Augustin
Bordeaux, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital Louis Pasteur
Le Coudray, , France
L'Hôpital Privé du Confluent
Nantes, , France
CHU Nîmes
Nîmes, , France
Polyclinique les Fleurs
Ollioules, , France
CHU de Poitiers
Poitiers, , France
Clinique Saint-Hilaire
Rouen, , France
Institut Arnaud Tzanck,
Saint-Laurent-du-Var, , France
Clinique Pasteur
Toulouse, , France
Institut Mutualiste montsouris
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Ziad Boueri, MD
Role: primary
Nicolas Meneveau, MD
Role: primary
Benjamin Séguy, MD
Role: primary
Frederic Casassus, MD
Role: primary
Géraud SOUTEYRAND, MD
Role: primary
Grégoire RANGé Rangé, MD
Role: primary
Erwan BRESSOLLETTE, MD
Role: primary
Guillaume Cayla, MD
Role: primary
Philippe Commeau, MD
Role: primary
Sébastien Levesque, MD
Role: primary
Quentin LANDOLFF, MD
Role: primary
Julien ADJEDJ, MD
Role: primary
Benjamin HONTON, MD
Role: primary
References
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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.
Other Identifiers
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CARDIO 04 2021
Identifier Type: -
Identifier Source: org_study_id
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