Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-21 @ 11:38 PM
Study NCT ID:
NCT03144960
Status:
UNKNOWN
Last Update Posted:
2017-05-09
First Post:
2017-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Of Acute Occlusion In Ischemic Stroke by Mechanical Thrombectomy', 'timeFrame': '18 months', 'description': 'Treatment of ischemic stroke patients after 4.5 hours from stroke onset by endovascular intervention by using Mechanical Thrombectomy techniques and without using Recombinant tissue-type plasminogen Activator and non eligible patients for Thrombectomy will be excluded.\n\nThe number of people will be participated into this study will be 20 aged 18 to 80 years old The patients will be undergoing NIHSS score , ASPECTS score The patients will be undergoing CT/CT angiography The patients will be undergoing mechanical thrombectomy Results will be collected and correlated with the prognosis of the outcomes'}], 'secondaryOutcomes': [{'measure': 'The patients will be undergoing NIHSS score', 'timeFrame': '1 hour', 'description': 'patients with NIHSS score less than 10 non eligible for mechanical thrombectomy'}, {'measure': 'The patients will be undergoing ASPECTS score', 'timeFrame': '1 hour', 'description': 'patients with ASPECTS score less than 6 non eligible for mechanical thrombectomy'}, {'measure': 'The patients will be undergoing CT/CT angiography', 'timeFrame': '2 hours', 'description': 'ct and ct angiography for exclusion of any bleeding or head injury'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Stroke']}, 'referencesModule': {'references': [{'pmid': '17258667', 'type': 'RESULT', 'citation': 'Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G; SITS-MOST investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007 Jan 27;369(9558):275-82. doi: 10.1016/S0140-6736(07)60149-4.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of Therapeutic benefits and hazards of Mechanical Thrombectomy in Ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.', 'detailedDescription': 'Stroke is an acute neurologic dysfunction of vascular origin with sudden or at least rapid occurrence of symptoms and signs corresponding to the involvement of focal areas in the brain.The two main types of stroke are ischemic and hemorrhagic.Thrombosis can form in the extracranial and intracranial arteries when the intima is roughened and plaque forms along the injured vessel.The endothelial injury permits platelets to adhere and aggregate, then coagulation is activated and thrombus develops at site of plaque.Blood flow through the extracranial and intracranial systems decreases, and the collateral circulation maintains function. When the compensatory mechanism of collateral circulation fails, perfusion is compromised, leading to decreased perfusion and cell death. Stroke is the third leading cause of death in the United States. Many people die each year from stroke in the United States.Stroke is the leading cause of serious, long-term disability in the United States. Nearly one fourth of strokes occur in people under the age of 65.High blood pressure is the most important risk factor for stroke. Intravenous recombinant tissue-type plasminogen activator is the only Food and Drug Administration approved treatment for acute ischemic stroke. Mechanical thrombectomy improves clinical outcomes in patients with acute ischemic stroke caused by a large vessel occlusion.There is no apparent benefit of intravenous thrombolysis to patients with ischemic stroke undergoing mechanical thrombectomy. The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged between 18 - 80 years old of both sex.\n2. Acute ischemic stroke due to proved large-artery occlusion.\n3. Ineligibility for IV thrombolysis.\n4. A timeframe of ≤ 4.5 hours between stroke onset and the start of mechanical thrombectomy.\n5. The patients included in this series should have an NIHSS score of at least 10 or fluctuating symptoms.\n6. ASPECTS of 6 or \\> 6\n7. All patients will be undergoing CT/CT angiography before and after treatment\n\nExclusion Criteria:\n\n1. Age older than 80 years or less than 18\n2. Cerebral haemorrhage.\n3. Acute infarction \\> 1/3 of middle cerebral artery (MCA) territory on CT-scan.\n4. A history of stroke in the last 6 weeks.\n5. A time interval of \\> 4.5 hours.\n6. laboratory evidence of coagulation abnormalities.\n7. Known arteriovenous malformation , neoplasm or aneurysm.\n8. Woman at child bearing age who has a positive pregnancy test'}, 'identificationModule': {'nctId': 'NCT03144960', 'briefTitle': 'Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke', 'orgStudyIdInfo': {'id': 'Thrombectomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'mechanical thrombectomy', 'description': 'The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset, mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption.', 'interventionNames': ['Procedure: Mechanical Thrombectomy']}], 'interventions': [{'name': 'Mechanical Thrombectomy', 'type': 'PROCEDURE', 'description': 'mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption', 'armGroupLabels': ['mechanical thrombectomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eman Khedr, Professor', 'role': 'CONTACT', 'email': 'emankhedr99@yahoo.com', 'phone': '+201005850632'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'AHMohamed', 'investigatorAffiliation': 'Assiut University'}}}}