Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-31 @ 5:31 AM
Study NCT ID:
NCT05020795
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2021-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3', 'timeFrame': 'Immediately after endovascular thrombectomy', 'description': 'Near complete-complete vessel recanalisation'}], 'secondaryOutcomes': [{'measure': 'Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3', 'timeFrame': 'Immediately after endovascular thrombectomy', 'description': 'Successful vessel recanalisation'}, {'measure': 'First pass effect (mTICI2c-3)', 'timeFrame': 'During endovascular thrombectomy procedure', 'description': 'Near complete-complete vessel recanalisation after the first pass attempt at clot retrieval'}, {'measure': 'New or distal vascular territory clot embolisation', 'timeFrame': 'Immediately after endovascular thrombectomy'}, {'measure': 'Modified Rankin Scale 0-2', 'timeFrame': '90 days', 'description': 'Good functional outcome based on the modified Rankin scale of disability'}, {'measure': 'Symptomatic intracranial haemorrhage', 'timeFrame': '24 hours after Endovascular thrombectomy'}, {'measure': 'National Institutes of Health of Stroke Scale (NIHSS)', 'timeFrame': '24 hours', 'description': 'Change in stroke severity'}, {'measure': 'Mortality', 'timeFrame': '90 days'}, {'measure': 'Total number of passes at clot retrieval', 'timeFrame': 'Immediately after endovascular thrombectomy'}, {'measure': 'Procedure related complications', 'timeFrame': 'Immediately after endovascular thrombectomy'}, {'measure': 'Total procedural time', 'timeFrame': 'Immediately after endovascular thrombectomy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Large vessel occlusion', 'Balloon guide catheter', 'Flow arrest', 'Mechanical thrombectomy', 'Endovascular thrombectomy'], 'conditions': ['Stroke', 'Occlusion, Cerebrovascular']}, 'referencesModule': {'references': [{'pmid': '39697177', 'type': 'DERIVED', 'citation': 'Dhillon PS, Butt W, Podlasek A, Bhogal P, Lynch J, Booth TC, McConachie N, Lenthall R, Nair S, Malik L, Goddard T, Carraro do Nascimento V, Barrett E, Jethwa K, Krishnan K, Dineen RA, England TJ; ProFATE Investigators. Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy (ProFATE): A Multicenter, Blinded-End Point, Randomized Clinical Trial. Stroke. 2025 Feb;56(2):371-379. doi: 10.1161/STROKEAHA.124.049715. Epub 2024 Dec 19.'}, {'pmid': '37231682', 'type': 'DERIVED', 'citation': 'Dhillon PS, Butt W, Podlasek A, Bhogal P, McConachie N, Lenthall R, Nair S, Malik L, Lynch J, Goddard T, Barrett E, Krishnan K, Dineen RA, England TJ. Effect of proximal blood flow arrest during endovascular thrombectomy (ProFATE): Study protocol for a multicentre randomised controlled trial. Eur Stroke J. 2023 Jun;8(2):581-590. doi: 10.1177/23969873231166194. Epub 2023 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'Endovascular thrombectomy (EVT) has become the standard of care for large vessel occlusion in acute ischaemic stroke (AIS). During clot-retrieval, simultaneous balloon inflation within the internal carotid artery offers transient proximal blood flow arrest, potentially preventing distal clot migration or embolisation to new vascular territories. Retrospective studies indicate that this may improve complete vessel recanalisation rates and may translate to improved functional independence. However, lack of high-quality evidence demonstrating the efficacy of simultaneous balloon inflation has led to clinical equipoise with heterogeneity of practice globally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Acute ischemic stroke presenting with a neurological deficit of (NIHSS ≥2)\n* Intracranial arterial occlusion of the distal internal carotid artery or middle cerebral artery (M1/M2 segments) demonstrated with on clinical neuroimaging such as: computed tomography angiogram (CTA), magnetic resonance imaging angiogram (MRA), or digital subtraction angiography (DSA).\n* ASPECTS score of \\>4 or by locally accepted ischaemic core/penumbra mismatch using computed tomography perfusion or magnetic resonance (CTP or MR) imaging.\n* modified Rankin Scale, mRS\\<3\n* Intention to treat with aspiration only or combination technique of stent-retriever + aspiration in the first pass attempt during endovascular thrombectomy\n\nExclusion Criteria:\n\n* Severe stenosis (\\>90%), or tandem occlusion of the ipsilateral extracranial internal carotid artery.\n* Previously deployed stents in the ipsilateral internal carotid artery.\n* Dissections of the ipsilateral internal carotid artery.\n* Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).\n* Subject participating in a study involving an investigational drug or device that would impact this study.'}, 'identificationModule': {'nctId': 'NCT05020795', 'acronym': 'ProFATE', 'briefTitle': 'Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy', 'organization': {'class': 'OTHER', 'fullName': 'Nottingham University Hospitals NHS Trust'}, 'officialTitle': 'Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy', 'orgStudyIdInfo': {'id': '21DI004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Balloon inflation', 'description': 'Endovascular thrombectomy with simultaneous balloon inflation using a balloon guide catheter', 'interventionNames': ['Procedure: Endovascular thrombectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No balloon inflation', 'description': 'Endovascular thrombectomy without simultaneous balloon inflation using a balloon guide catheter', 'interventionNames': ['Procedure: Endovascular thrombectomy']}], 'interventions': [{'name': 'Endovascular thrombectomy', 'type': 'PROCEDURE', 'description': 'Clot retrieval for large vessel occlusion in acute ischaemic stroke', 'armGroupLabels': ['Balloon inflation', 'No balloon inflation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Permesh Singh Dhillon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottingham University Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}