Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT02455661
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2015-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Radial closure by TR-Band.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2015-05-14', 'studyFirstSubmitQcDate': '2015-05-24', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular complications at the arterial access site', 'timeFrame': '30 days', 'description': 'Occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems'}, {'measure': 'Adverse cardiac events', 'timeFrame': '30 days', 'description': 'Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).'}, {'measure': 'Adverse cardiac events', 'timeFrame': '12 months', 'description': 'Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arterial Closure Device', 'Percutaneous Coronary Intervention (PCI)', 'Access Site Bleeding', 'Adverse Cardiac Events']}, 'referencesModule': {'references': [{'pmid': '28209184', 'type': 'DERIVED', 'citation': 'Sartorius B, Behnes M, Unsal M, Hoffmann U, Lang S, Mashayekhi K, Borggrefe M, Akin I. Arterial access-site complications after use of a vascular closure device related to puncture height. BMC Cardiovasc Disord. 2017 Feb 16;17(1):64. doi: 10.1186/s12872-017-0484-7.'}, {'pmid': '27803954', 'type': 'DERIVED', 'citation': 'Fastner C, Behnes M, Unsal M, El-Battrawy I, Ansari U, Mashayekhi K, Hoffmann U, Lang S, Kuschyk J, Borggrefe M, Akin I. Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention: the FERARI study. Heart Vessels. 2017 May;32(5):520-530. doi: 10.1007/s00380-016-0901-3. Epub 2016 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'FERARI is a single centre observational study comparing patients undergoing PCI either using radial compression devices or femoral closure devices at the corresponding access site.\n\nFirst primary outcomes consist of the occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems\n\nSecond primary outcomes consist of the occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days and 12 months of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent about the study\n* Elective PCI with following indications:\n\nStable coronary artery disease, proven myocardial ischemia; cardiac arrhythmia; syncope; Unstable AP defined as NSTEMI but without cardiac troponin elevation; NSTEMI; STEMI\n\n* patient eligible for coronary angiography and both radial and femoral PCI\n* requirement of using a vascular closure device (without contraindications)\n\nExclusion Criteria:\n\n* inability to understand and sign the informed consent term\n* pregnancy\n* less 18 years of age\n* single diagnostic coronary angiography\n* active or high bleeding risk (thrombocytopenia \\<50,000/µl)\n* femoral approach and PCI without using a vascular closure device\n* other conditions hampering involvement in the study'}, 'identificationModule': {'nctId': 'NCT02455661', 'acronym': 'FERARI', 'briefTitle': 'Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'orgStudyIdInfo': {'id': '2014-560N-MA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radial PCI with TR Band (TM)', 'description': 'Patients with a PCI using the radial approach and the above radial compression device.', 'interventionNames': ['Device: TR Band (TM)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral PCI with AngioSeal device', 'description': 'Patients with a PCI using the femoral approach and the above femoral vascular closure device.', 'interventionNames': ['Device: AngioSeal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral PCI with StarClose device', 'interventionNames': ['Device: StarClose']}], 'interventions': [{'name': 'TR Band (TM)', 'type': 'DEVICE', 'armGroupLabels': ['Radial PCI with TR Band (TM)']}, {'name': 'AngioSeal', 'type': 'DEVICE', 'armGroupLabels': ['Femoral PCI with AngioSeal device']}, {'name': 'StarClose', 'type': 'DEVICE', 'armGroupLabels': ['Femoral PCI with StarClose device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'First Department of Medicine, University Medical Centre Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sub-PI', 'investigatorFullName': 'Michael Behnes', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}