Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 9:54 PM
Study NCT ID:
NCT06877195
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2025-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ri-revascularization of grafted territory', 'timeFrame': 'Till end of study (at least three years)', 'description': 'Incidence of coronary ri-revascaularization by either angioplasty or surgical bypass concerning the grafted territory due to graft failure'}], 'secondaryOutcomes': [{'measure': 'Major Cardiovascular and Cerebrovascular Events (MACCE)', 'timeFrame': 'Till end of study (at least three years)', 'description': 'Incidence of Major Cardiovascular and Cerebrovascular Events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Bypass Graft'], 'conditions': ['Ischemic Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'Multicentre randomised prospective study aimed at verifying medium-term patency of venous grafts on the right coronary artery territory, by clinical and/or instrumental follow-up with particular attention to clinically driven re-revascularisation events regarding the site of new lesions (granularly comparing sites already treated with VEST, sites treated with bare vein, sites treated with other conduits, de novo lesions on the native).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* combined or isolated interventions\n* adequate vein calibre\n* adequate graft flowmetry\n\nExclusion Criteria:\n\n* inability to implant due to calibre disparity or inadequate flowmetry'}, 'identificationModule': {'nctId': 'NCT06877195', 'acronym': 'RiVEST', 'briefTitle': 'Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory', 'organization': {'class': 'OTHER', 'fullName': 'Cardiochirurgia E.H.'}, 'officialTitle': 'Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory: Mid-term Clinically Driven Re-rivascularization Events Comparison Between Sites Treated With VEST, Sites Treated With Bare Vein, Sites Treated With Other Conduits and de Novo Lesions on the Native Vessels', 'orgStudyIdInfo': {'id': 'MCRiVEST-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vested vein', 'description': 'Usage of External mesh support (VEST) around the venous graft', 'interventionNames': ['Procedure: CABG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unvested vein', 'description': 'Normally harvested and preserved "naked" vein used as a graft', 'interventionNames': ['Procedure: CABG']}], 'interventions': [{'name': 'CABG', 'type': 'PROCEDURE', 'description': 'Aortocoronary bypass procedures with venous grafts on right coronary territory', 'armGroupLabels': ['Unvested vein', 'Vested vein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00149', 'city': 'Roma', 'state': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Paolo Weltert, MD', 'role': 'CONTACT', 'email': 'lweltert@gmail.com', 'phone': '+393478880617'}, {'name': 'Luca Paolo Weltert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'European Hospital', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Luca Paolo Weltert, MD', 'role': 'CONTACT', 'email': 'lweltert@gmail.com', 'phone': '+393478880617'}], 'overallOfficials': [{'name': 'Luca Paolo Weltert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unicamillus'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Form start to end of study', 'ipdSharing': 'YES', 'description': 'Anonimized clinical parameters', 'accessCriteria': 'Centers collaborating to active recruitment, to be added after the completion of their each institutional review'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiochirurgia E.H.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}