Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-07 @ 4:44 AM
Study NCT ID:
NCT06149650
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2023-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound healing and freedom from amputation', 'timeFrame': '12 months', 'description': 'Composite of wound healing defined as the healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening) and freedom from amputation defined as the absence of any amputation of the treated limb: minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure).'}], 'secondaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': '24 months', 'description': 'Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening)'}, {'measure': 'Freedom from amputation', 'timeFrame': '24 months', 'description': 'Absence of any amputation of the treated limb: minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure).'}, {'measure': 'Amputation-free survival', 'timeFrame': 'through study completion, approximately 2 years', 'description': 'time between IVL treatment and amputation of the target limb, minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure)'}, {'measure': 'Change in Rutherford classification category', 'timeFrame': '12 and 24 months', 'description': 'Seven classification categories, from 0 (asymptomatic) to 6 (Major tissue loss)'}, {'measure': 'Change in foot ischemia', 'timeFrame': '12 and 24 months', 'description': 'Change in ankle-brachial index or toe pressure, depending on which data is available'}, {'measure': 'Change in WIfi score', 'timeFrame': '12 and 24 months', 'description': 'Three-digit score for comprehensive assessment of wound, ischemia and foot infection'}, {'measure': 'Freedom from clinically-driven target lesion revascularization (CD-TLR)', 'timeFrame': '12 and 24 months', 'description': 'freedom from any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion.'}, {'measure': 'CD-TLR-free survival', 'timeFrame': 'through study completion, approximately 2 years', 'description': 'time between IVL treatment and any endovascular re-intervention to the target lesion (± 10 mm)'}, {'measure': 'Primary patency rate', 'timeFrame': '12 and 24 months', 'description': 'freedom from total occlusion without any endovascular or surgical re-intervention to the target lesion (± 10 mm)'}, {'measure': 'Assisted primary patency rate', 'timeFrame': '12 and 24 months', 'description': 'freedom from total occlusion following additional endovascular or surgical intervention(s) due to restenosis of the target lesion'}, {'measure': 'Secondary patency rate', 'timeFrame': '12 and 24 months', 'description': 'freedom from total occlusion following additional endovascular or surgical intervention(s) due to occlusion of the target lesion'}, {'measure': 'Technical success of IVL', 'timeFrame': 'on the day of the procedure', 'description': 'residual diameter stenosis ≤30% after IVL and before any potential adjunctive intervention'}, {'measure': 'Overall procedural success', 'timeFrame': 'on the day of the procedure', 'description': 'residual stenosis ≤30% by the end of the complete procedure'}, {'measure': 'Frequency and severity of procedural complications and other adverse events', 'timeFrame': 'Within 30 days after the procedure', 'description': 'Grading according to the classification system of the Cardiovascular and Interventional Radiological Society of Europe (PMID: 28584945)'}, {'measure': 'Patient-reported health-related quality-of-life', 'timeFrame': 'at 6, 12 and 24 months', 'description': 'EuroQol questionnaire EQ-5D-5L'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CLTI'], 'conditions': ['Chronic Limb-Threatening Ischemia']}, 'descriptionModule': {'briefSummary': "CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (CLTI). The primary objective of CALCIO is to understand the effectiveness of IVL in promoting wound healing and preventing amputation. The secondary objectives of CALCIO are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CLTI patients with calcified femoropopliteal or crural lesions visible on fluoroscopy and treated with Intravascular Lithotripsy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with chronic limb-threatening ischemia (Rutherford Category ≥4)\n* Femoropopliteal and/or crural calcified lesions visible on fluoroscopy;\n* Treatment with IVl using the Shockwave Medical IVL System.\n\nExclusion Criteria:\n\n* \\< 18 years old;\n* Incapacity or refusal to give informed consent;\n* Ongoing pregnancy;\n* Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.'}, 'identificationModule': {'nctId': 'NCT06149650', 'acronym': 'CALCIO', 'briefTitle': 'Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Cardiovascular and Interventional Radiological Society of Europe'}, 'officialTitle': 'Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study', 'orgStudyIdInfo': {'id': 'CALCIO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Full cohort', 'description': 'Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care', 'interventionNames': ['Device: Shockwave Medical IVL System']}], 'interventions': [{'name': 'Shockwave Medical IVL System', 'type': 'DEVICE', 'description': 'Comprehensive system consisting of generator, a connector cable and a single-use sterile catheter with integrated balloon for intravascular lithotripsy of peripheral artery calcification.', 'armGroupLabels': ['Full cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57072', 'city': 'Siegen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'St Marien-Krankenhaus', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': 'NW3 2QG', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Free London NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'St George's University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Claire Poulet, Dr', 'role': 'CONTACT', 'email': 'calcio@cirse.org', 'phone': '+431904200371'}], 'overallOfficials': [{'name': 'Raman Uberoi, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Oxford University Hospital NHS Foundation Trust, Oxford, United Kingdom'}, {'name': 'Christoph Binkert, Prof. Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Cantonal Hospital Winterthur, Winterthur, Switzerland'}, {'name': 'Peter Reimer, Prof. Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Municipal Clinic Karlsruhe, Karlsruhe, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovascular and Interventional Radiological Society of Europe', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shockwave Medical, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}