Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT06720935
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2024-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Coils During Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003323', 'term': 'Coronary Aneurysm'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-09-29', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Technical Success', 'timeFrame': 'intraprocedural', 'description': 'Rate of technical success is defined as effective sealing of coronary perforation or coronary fistulas/aneurysm after coils embolization'}], 'secondaryOutcomes': [{'measure': 'Rate of Procedural success', 'timeFrame': 'Intraprocedural', 'description': 'Rate of technical success without In Hospital Major Cardiovascular Events including death, target vessel myocardial infarction and re-PCI or CABG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coils', 'Coronary Artery Perforation', 'Coronary Fistulas', 'Coronary aneurysm'], 'conditions': ['Percutaneous Coronary Intervention (PCI)', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes. The study aims to report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.', 'detailedDescription': 'Background. Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes Objectives. To report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.\n\nMethods. Among 245.652 PCIs performed in 17 high-volume European centers, patients treated with coils will be identified.\n\nThe primary outcome was technical success, defined as the successful sealing coronary perforation or aneurysm/fistulas and procedural success defined as technical success without in-hospital Major Cardiovascular Events (MACe). Long-term MACE and mortality were also reported'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery perforation or coronary fistula/aneurysm treated with coils embolization during percutaneous coronary intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary artery perforation or coronary artery fistula/aneurysm suitable treating with coils embolization\n\nExclusion Criteria:\n\n* Patients without coronary artery disease suitable of coils treatment'}, 'identificationModule': {'nctId': 'NCT06720935', 'acronym': 'COILSEAL', 'briefTitle': 'Use of Coils During Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'San Luigi Gonzaga Hospital'}, 'officialTitle': 'Contemporary Use of Coils During Percutaneous Coronary Intervention: From the Multicenter COILSEAL Registry', 'orgStudyIdInfo': {'id': '002-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing to percutaneous coronary intervention with coils', 'description': 'The study involves patients undergoing coils embolization for treating coronary artery perforation or coronary fistulas/aneurysm during percutaneous coronary intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10098', 'city': 'Orbassano', 'state': 'Turin', 'country': 'Italy', 'facility': 'San Luigi Gonzaga Hospital', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Luigi Gonzaga Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Interventional Cardiologist', 'investigatorFullName': 'Enrico Cerrato', 'investigatorAffiliation': 'San Luigi Gonzaga Hospital'}}}}