Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-26 @ 1:03 AM
Study NCT ID:
NCT04761068
Status:
RECRUITING
Last Update Posted:
2021-02-18
First Post:
2021-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Patients Undergoing CABG Surgery With VEST Supported Venous Grafts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemic driven target vessel revascularization', 'timeFrame': '5 years post Index CABG', 'description': 'CABG or PCI of VEST supported vein graft or associated target coronary artery'}], 'secondaryOutcomes': [{'measure': 'MACCE', 'timeFrame': '1, 2, and 5 years post index CABG', 'description': 'The occurrence of any of the following major adverse cardiac and cerebrovascular events (MACCE): death; Stroke; Myocardial infarction (MI) and Coronary revascularization (redo-CABG and PCI).'}, {'measure': 'Myocardial Infarction (MI)', 'timeFrame': '1, 2, and 5 years post index CABG', 'description': 'Myocardial Infarction (MI)'}, {'measure': 'Recurrent revascularization', 'timeFrame': '1, 2, and 5 years post index CABG', 'description': 'Recurrent revascularization'}, {'measure': 'Survival', 'timeFrame': '1, 2, and 5 years post index CABG', 'description': 'Survival, both overall and freedom from cardiac death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary artery bypass surgery', 'CABG', 'External support'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective, investigator-initiated, multi-center, open label and post-market registry, enrolling patients with atherosclerotic coronary artery disease, scheduled for CABG with at least one SVG bypass.\n\nThe registry is designed to evaluate the clinical outcome of CABG surgery with an external support device (VEST) for SVG bypasses.\n\nIn each patient, use of the VEST will be according to its approved indications for use and attempt will be made (based on clinical judgement) to support each non-sequential SVG bypass graft with a VEST device.\n\nSubjects will be followed for 5 years, with interim follow ups at 12 and 24 months.\n\nMACCE and EQ5D3L will be documented at every follow up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment.\n2. Saphenous vein graft length and diameter are adequate for the planned intervention.\n3. Patient is willing and able to give their written informed consent to participate in the registry study.\n4. Patient is over 18 years of age\n\nExclusion Criteria:\n\n1. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)\n2. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study'}, 'identificationModule': {'nctId': 'NCT04761068', 'briefTitle': 'Clinical Outcomes of Patients Undergoing CABG Surgery With VEST Supported Venous Grafts', 'organization': {'class': 'OTHER', 'fullName': 'Cardiocentro Ticino'}, 'officialTitle': 'Clinical Outcomes of Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery With VEST Supported Venous Grafts', 'orgStudyIdInfo': {'id': 'VEST registry'}}, 'armsInterventionsModule': {'interventions': [{'name': 'VEST', 'type': 'DEVICE', 'description': 'Venous External Support for vein grafts in CABG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Nikolaus Bonaros, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Sigrid Sandner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AKH (Vienna General Hospital)', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Martin Grabenwoger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Floridsdorf Clinic', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Dresden', 'status': 'TERMINATED', 'country': 'Germany', 'facility': 'Herzzentrum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Nuremberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Theodor Fischlein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Nürnberg', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'city': 'Trier', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ivar Friedrich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus der Barmherzigen Brüder', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Waltert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'European hospital', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Centofanti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mauriziano Hospital', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'city': 'Badalona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Christian Muñoz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Santa Cruz de Tenerife', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pilar Garrido, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital of the Canary Islands', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Antonio Margarit, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ribera hospital', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Lugano', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Stefanos Demertzis, Professor', 'role': 'CONTACT'}, {'name': 'Stefanos Demertzis, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiocentro Ticino', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Omer Dzemali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Triemli University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Stefanos Demertzis, Professor', 'role': 'CONTACT', 'email': 'Stefanos.Demertzis@cardiocentro.org', 'phone': '+41918053147'}], 'overallOfficials': [{'name': 'Stefanos Demertzis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiocentro Ticino'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiocentro Ticino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of cardiac surgery', 'investigatorFullName': 'Stefanos Demertzis', 'investigatorAffiliation': 'Cardiocentro Ticino'}}}}