Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT01400360
Status:
UNKNOWN
Last Update Posted:
2011-07-22
First Post:
2011-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020301', 'term': 'Vasospasm, Intracranial'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'lastUpdateSubmitDate': '2011-07-21', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New infarcts between baseline and final MRI', 'timeFrame': '21 + - 7 days'}], 'secondaryOutcomes': [{'measure': 'Clinical outcome (mRS, Karnofsky)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral vasospasm', 'subarachnoid hemorrhage', 'transluminal balloon angioplasty', 'intraarterial treatment'], 'conditions': ['Cerebral Vasospasm After Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount of transient or even permanent neurological deficits and poor outcome of the patients. Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators represents a rescue therapy for severe CVS. Indication, duration and efficacy of this treatment, however, is still under debate. Aim of the study is to investigate if such a rescue treatment can significantly reduce new delayed ischemic cerebral deficits after SAH. Hypothesis is that the occurance of delayed infarcts can be reduced by repetetive intraarterial therapy to more than 50 %.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SAH (WFNS 1-4)\n* Perfusion relevant CVS\n* Ability for MRI, DSA and intraarterial treatment\n\nExclusion Criteria:\n\n* extended cerebral infarcts\n* SAH or ICH from AVM or flow associated aneurysm\n* Non aneurismal SAH\n* Relevant non spastic stenosis of brain supplying arteries'}, 'identificationModule': {'nctId': 'NCT01400360', 'acronym': 'IMCVS', 'briefTitle': 'Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'JohannWGUH_IMCVS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'invasive', 'description': 'After proof of perfusion relevant CVS in interventional therapy should be performed as best possible combination from TBA and intraarterial vasodilators additional to the conventional treatment.', 'interventionNames': ['Other: Combination of TBA and intraarterial application of vasodilators']}, {'type': 'NO_INTERVENTION', 'label': 'conventional', 'description': 'After proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy).', 'interventionNames': ['Other: Combination of TBA and intraarterial application of vasodilators']}], 'interventions': [{'name': 'Combination of TBA and intraarterial application of vasodilators', 'type': 'OTHER', 'description': 'In the invasive arm CVS should be treated by intraarterial therapy and efficacy controlled by CT or MRI after 48 hours and if necessary repeated.', 'armGroupLabels': ['conventional', 'invasive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Neurochirurgische Klinik, Universitätsklinik', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '60528', 'city': 'Frankfurt am Main', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hartmut Vatter, M. D.', 'role': 'CONTACT', 'email': 'h.vatter@em.uni-frankfurt.de', 'phone': '069/ 6301', 'phoneExt': '5939'}, {'name': 'Joachim Berkefeld, M. D.', 'role': 'CONTACT', 'email': 'j.berkefeld@em.uni-frankfurt.de', 'phone': '069/ 6301', 'phoneExt': '5462'}], 'facility': 'Department of Neurosurgery, Johann Wolfgang Goethe-University', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '89312', 'city': 'Günzburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ralph König, M. D.', 'role': 'CONTACT', 'email': 'ralph.koenig@uni-ulm.de', 'phone': '08221', 'phoneExt': '9600'}, {'name': 'Ralph König, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neurochirurgische Klinik der Universität Ulm', 'geoPoint': {'lat': 48.45599, 'lon': 10.27695}}, {'zip': '07743', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rolf Kalff, M. D.', 'role': 'CONTACT', 'email': 'rolf.kalff@med.uni-jena.de', 'phone': '093641', 'phoneExt': '9323001'}, {'name': 'Steffi Neumann', 'role': 'CONTACT', 'email': 'steffi.neumann@med.uni-jena.de', 'phone': '03641', 'phoneExt': '9324765'}, {'name': 'Rolf Kalff, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinik für Neurochirurgie, Universitätsklinikum', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '68169', 'city': 'Mannheim', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Klinik für Neurochirurgie, Universitätsklinikum', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'centralContacts': [{'name': 'Hartmut Vatter, M. D.', 'role': 'CONTACT', 'email': 'h.vatter@em.uni-frankfurt.de', 'phone': '069 / 6301', 'phoneExt': '5939'}, {'name': 'Joachim Berkefeld, M. D.', 'role': 'CONTACT', 'email': 'j.berkefeld@em.uni-frankfurt.de', 'phone': '069/ 6301', 'phoneExt': '5462'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hartmut Vatter, M.D.', 'oldOrganization': 'Dept. of Neurosurgery, Goethe-University Frankfurt'}}}}