Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05301218
Status:
UNKNOWN
Last Update Posted:
2022-11-15
First Post:
2022-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CAlcified Lesion Intervention Planning Steered by OCT.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020163', 'term': 'Ornithine Carbamoyltransferase Deficiency Disease'}], 'ancestors': [{'id': 'D056806', 'term': 'Urea Cycle Disorders, Inborn'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017130', 'term': 'Angioplasty'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2022-03-08', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run', 'timeFrame': 'During the procedure', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria', 'timeFrame': 'during procedure', 'description': 'After the stent is deployed, the blood flow dynamics influence the mechanics by compressing and expanding the structure.'}, {'measure': 'Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods)', 'timeFrame': 'during procedure', 'description': 'Qualitative Comparative Analysis (QCA) is a methodology that enables the analysis of multiple cases in complex situations'}, {'measure': 'Residual major struts malapposition: crude incidence and quantification', 'timeFrame': 'during procedure', 'description': '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.'}, {'measure': 'Major adverse cardiovascular events at 30 days and 1 year', 'timeFrame': 'at 30 days and 1 year', 'description': 'Cardiovascular death + Any myocardial infarction + need for re-intervention on the target lesion (TLR)'}, {'measure': 'Peri-procedural MI according to the SCAI definition (23)', 'timeFrame': 'during procedure', 'description': 'according to the SCAI definition (Moussa et al., Journal of the American College of Cardiology 2013)'}, {'measure': 'Coronary artery perforation: incidence', 'timeFrame': 'during the procedure and During the full participation period (1 year).]', 'description': 'Coronary perforation was defined as evidence of extravasation of dye or blood from the coronary artery during or following the interventional procedure'}, {'measure': 'Radiation dose', 'timeFrame': 'during procedure', 'description': 'Differences in dose radiation used during le procedure'}, {'measure': 'Total Contrast medium volume', 'timeFrame': 'during procedure', 'description': 'Differences in amount of contrast drug used during le procedure'}, {'measure': 'Procedure duration', 'timeFrame': '24th post-operative hour', 'description': 'differences in duration (time) of the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Optical Coherence Tomography, OCT', 'minimal stent area(MSA)'], 'conditions': ['Coronary Artery Calcification', 'Angioplasty']}, 'referencesModule': {'references': [{'pmid': '40305015', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Calcified lesions are very frequent among coronary artery disease stenotic lesions.\n\nThe prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.\n\nCalcified 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient with chronic coronary syndrome\n2. Angiographically moderately to severely calcified target lesion, defined as follows:\n\n * Moderate: lesion with radio-opacities noted only during the cardiac cycle before contrast dye injection (Aksoy et al., Circ Cardiovasc Interv 2019)\n * 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)\n3. Possibility to cross the target lesion with OCT catheter\n\nExclusion Criteria:\n\n1. On-going cardiogenic shock\n2. Acute coronary syndrome related to target lesion\n3. Severe renal failure (Creatinine clearance: 30 ml/min/m2)\n4. Impossibility to cross target lesion with OCT catheter \\& balloons,\n5. Indication for Rotablator device as first line therapy\n6. Pregnancy\n7. Age \\< 18 y\n8. Denial to provide consent'}, 'identificationModule': {'nctId': 'NCT05301218', 'acronym': 'CALIPSO', 'briefTitle': 'CAlcified Lesion Intervention Planning Steered by OCT.', 'organization': {'class': 'OTHER', 'fullName': 'Institut Mutualiste Montsouris'}, 'officialTitle': 'CAlcified Lesion Intervention Planning Steered by OCT.', 'orgStudyIdInfo': {'id': 'CARDIO 04 2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'angiography-guided group', 'description': '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.', 'interventionNames': ['Procedure: angioplasty']}, {'type': 'EXPERIMENTAL', 'label': 'OCT-guided group', 'description': '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.', 'interventionNames': ['Procedure: angioplasty']}], 'interventions': [{'name': 'angioplasty', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['OCT-guided group', 'angiography-guided group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20600', 'city': 'Bastia', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ziad Boueri, MD', 'role': 'CONTACT'}], 'facility': 'Ch de Bastia', 'geoPoint': {'lat': 42.70219, 'lon': 9.45123}}, {'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas Meneveau, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin Séguy, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33200', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frederic Casassus, MD', 'role': 'CONTACT'}], 'facility': 'Clinique Saint Augustin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Géraud SOUTEYRAND, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '28630', 'city': 'Le Coudray', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Grégoire RANGé Rangé, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Louis Pasteur', 'geoPoint': {'lat': 48.42115, 'lon': 1.50057}}, {'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Erwan BRESSOLLETTE, MD', 'role': 'CONTACT'}], 'facility': "L'Hôpital Privé du Confluent", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume Cayla, MD', 'role': 'CONTACT'}], 'facility': 'CHU Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '83190', 'city': 'Ollioules', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Commeau, MD', 'role': 'CONTACT'}], 'facility': 'Polyclinique les Fleurs', 'geoPoint': {'lat': 43.1399, 'lon': 5.84766}}, {'zip': '86000', 'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sébastien Levesque, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Quentin LANDOLFF, MD', 'role': 'CONTACT'}], 'facility': 'Clinique Saint-Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '06700', 'city': 'Saint-Laurent-du-Var', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien ADJEDJ, MD', 'role': 'CONTACT'}], 'facility': 'Institut Arnaud Tzanck,', 'geoPoint': {'lat': 43.67323, 'lon': 7.19}}, {'zip': '31300', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin HONTON, MD', 'role': 'CONTACT'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Silvia Burbassi, PhD', 'role': 'CONTACT', 'email': 'silvia.burbassi@imm.fr', 'phone': '0156616983', 'phoneExt': '33'}, {'name': 'Nicolas Amabile, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Mutualiste montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Nicolas Amabile, MD PhD', 'role': 'CONTACT', 'email': 'nicolas.amabile@imm.fr', 'phone': '0156616983', 'phoneExt': '33'}, {'name': 'Silvia Burbassi, PhD', 'role': 'CONTACT', 'email': 'silvia.burbassi@imm.fr', 'phone': '0156616983', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Nicolas Amabile, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Mutualiste Montsouris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}