Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT03451903
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Which Factors Influence the Duration and the Success of Mechanical Thrombectomy During the Acute Phase of Cerebral Infarction?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of the procedure', 'timeFrame': 'From the beginning of mechanical thrombectomy to the end of the procedure.', 'description': 'It is the period of time between when the artery is punctured and when the first image from the first cerebral angiographic test is acquired after revascularisation, which is used to calculate the rate of revascularisation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'thrombectomy', 'procedure time', 'revascularisation', 'thrombolytic therapy'], 'conditions': ['Acute Stroke']}, 'descriptionModule': {'briefSummary': 'This study aims to identify factors influencing the time span and success of reperfusion after a mechanical thrombectomy in the acute phase of cerebral infarction, and in particular the effect of intra-venous thrombolysis.', 'detailedDescription': 'Mechanical thrombectomy (MT), associated with standard IV thrombolysis (IVT) treatment, is effective during the acute phase of cerebral infarction with proximal occlusion of the anterior circulation in reducing disability at three months. MT-only treatment has only been assessed retrospectively in subgroups of controlled studies, with a significant difference in favour of the treatment. These results have led to a discussion about the benefits of MT without IVT in cases of proximal occlusion or carotid terminus occlusion. Recent data are in favour of a better prognosis for patients benefiting from a combined procedure. The impact of IVT on the implementation of MT is widely disputed, in particular the speed of execution, which could be enhanced by IVT. The factors influencing the time span and success of reperfusion after an MT are still not well-known, IVT in particular. The investigators have made the assumption that IVT could have an effect on the success of MT by shortening the duration of the procedure and increasing the likelihood of satisfactory revascularisation.\n\nThe investigators carried out a retrospective study based on data gathered prospectively by the Franche-Comté Stroke Registry. The investigators also considered other factors which could have affected the duration of the procedure or the rate of satisfactory revascularisation, including location of infarct, thrombus size and stroke aetiology.\n\nHypothesis: the investigators have made the assumption that IVT could have an effect on the success of MT by shortening the duration of the procedure and increasing the likelihood of satisfactory revascularisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had undergone an arteriography for cerebral infarction prior to mechanical thrombectomy at CHRU Besançon. Data are prospectively collected in the Franche-Comté Stroke Registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute phase of cerebral infarction\n* all patients who had undergone an arteriography for cerebral infarction prior to mechanical thrombectomy at CHRU Besançon\n* from 1st January 2015 to 31st December 2016\n\nExclusion Criteria:\n\n* Patients whose procedures were interrupted (puncture failure, catheterisation of the common or internal carotid artery failure)\n* Patients whose arteries were recanalised during the diagnostic arteriography'}, 'identificationModule': {'nctId': 'NCT03451903', 'acronym': 'REPAIR-FC', 'briefTitle': 'Which Factors Influence the Duration and the Success of Mechanical Thrombectomy During the Acute Phase of Cerebral Infarction?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Which Factors Influence the Duration and the Success of Mechanical Thrombectomy During the Acute Phase of Cerebral Infarction?', 'orgStudyIdInfo': {'id': 'P/2017/348'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mechanical thrombectomy group', 'description': 'Patients with acute stroke treated by mechanical thrombectomy.', 'interventionNames': ['Procedure: Mechanical thrombectomy']}, {'label': 'Combined procedure group', 'description': 'Patients with acute stroke treated by intravenous thrombolysis (with actilyse) and mechanical thrombectomy.', 'interventionNames': ['Drug: Actilyse', 'Procedure: Mechanical thrombectomy']}], 'interventions': [{'name': 'Actilyse', 'type': 'DRUG', 'otherNames': ['rtPA'], 'description': 'Actilyse is the intra-venous agent used for intra-venous thrombolysis in the acute phase of cerebral infarction.', 'armGroupLabels': ['Combined procedure group']}, {'name': 'Mechanical thrombectomy', 'type': 'PROCEDURE', 'description': 'Mechanical thrombectomy is an endovascular procedure by which an arterial clot is retrieved, in order to reperfuse the brain.', 'armGroupLabels': ['Combined procedure group', 'Mechanical thrombectomy group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Louise Bonnet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'J Minjoz Besancon university Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}