Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-25 @ 12:45 PM
Study NCT ID:
NCT05531461
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2022-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognition and Imaging With Tigertriever
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 424}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2022-09-04', 'studyFirstSubmitQcDate': '2022-09-04', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between successful reperfusion* and cognitive benefit**', 'timeFrame': '180 days post treatment', 'description': '\\*successful reperfusion is defined as eTICI ≥2b50 with the Tigertriever device.\n\n* Cognitive benefit is defined as change in Montreal Cognitive Assessment (MoCA) of 1.5 Standard Deviations (SD) from 4 days post treatment (or discharge if earlier) and 180 days post treatment; or MoCA ≥26 at 180 days post treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The objective of the COGNITIVE Study is to evaluate whether successful reperfusion with Tigertriever is associated with cognitive benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The COGNITIVE Study will include male or female subjects age 18-75 who present with LVO and treated with the Tigertriever as indicated per approved IFU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as indicated per the approved IFU.\n2. Tigertriever was used as the first line treatment in the target vessel.\n3. A signed informed consent.\n4. Age 18-75 years (inclusive).\n5. No known significant pre-stroke disability (pre-stroke mRS 0 or 1).\n\nExclusion Criteria:\n\n1. Use of any other IA recanalization device prior to the Tigertriever in the target vessel, including aspiration catheter.\n2. Evidence of acute brain hemorrhage on CT and/or MRI at admission.\n3. Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months.\n4. Probable cerebral amyloid angiopathy.\n5. Pre-stroke diagnosed dementia and/or prescribed cholinesterase inhibitors.\n6. Pre-stroke diagnosed and/or currently treated major depression.\n7. Pre-stroke learning or intellectual disability.\n8. Anticipated inability to obtain 6-month follow-up assessments.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT05531461', 'acronym': 'COGNITIVE', 'briefTitle': 'Cognition and Imaging With Tigertriever', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rapid Medical'}, 'officialTitle': 'COGNITIVE Study- Cognition and Imaging With Tigertriever', 'orgStudyIdInfo': {'id': 'COGNITIVE Study'}}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Saima Chaabane', 'role': 'CONTACT', 'email': 'SChaabane@mednet.ucla.edu', 'phone': '310-794-4482'}, {'name': 'Tateshima Satoshi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Mueller', 'role': 'CONTACT', 'email': 'Stephanie.Mueller@corewellhealth.org', 'phone': '616-267-1072'}, {'name': 'Paul Mazaris, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Corewell Health Research Institute', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '10595', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cristina Falo', 'role': 'CONTACT', 'email': 'cristina.falo@wmchealth.org', 'phone': '914-493-8194'}, {'name': 'Chirag Gandhi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westchester Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Walid Haddad, Dr.', 'role': 'CONTACT', 'email': 'walid@rapid-medical.com', 'phone': '+972 72 2503331'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rapid Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}