Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-01 @ 10:54 PM
Study NCT ID:
NCT05911568
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2023-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With Endovascular Intervention for STroke Patients With Existing Disability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic 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': 'D011216', 'term': 'Practice Management, Medical'}], 'ancestors': [{'id': 'D020399', 'term': 'Practice Management'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1060}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'modified Rankin Scale (mRS)', 'timeFrame': 'At hospital discharge', 'description': 'Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': '90 (±14) days after treatment initiation', 'description': 'Montreal Cognitive Assessment (MoCA) (Note: MoCA range: 0-30, higher scores mean better outcome)'}, {'measure': 'Barthel Index Scale', 'timeFrame': '90 (±14) days after treatment initiation', 'description': 'Barthel Index range: 0-100, higher scores mean participant is independent'}, {'measure': 'Initial residence level or better time during first 90 days post-stroke', 'timeFrame': '90 days after treatment initiation', 'description': 'Number of days spend at the initial residence level or better during the first 90 days post-stroke'}, {'measure': "Zarit's Burden Interview (ZBI)", 'timeFrame': '90 (±14) days after treatment initiation', 'description': 'ZBI is a measure of caregiving burden that includes a 22 item interview. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). We will use the 4 item version of the ZBI which has good correlation with the full version.'}, {'measure': 'Extended Thrombolysis in Cerebral Ischemia scale', 'timeFrame': 'At the end of EVT procedure', 'description': 'The 7-point scale of eTICI is as follows: eTICI0 = 0% reperfusion; eTICI 1 = minimal flow past the occlusion but no perfusion ; eTICI2a = 1-49% reperfusion; eTICI2b50 = 50-66% reperfusion; eTICI2b67 = 67-89% reperfusion; eTICI2c = 90-99% reperfusion; eTICI3 = complete reperfusion'}, {'measure': 'Death', 'timeFrame': '90 (±14) after treatment initiation'}, {'measure': 'Symptomatic intracranial hemorrhage', 'timeFrame': '24 (±6) hours', 'description': 'Evaluate modified Heidelberg definition'}], 'primaryOutcomes': [{'measure': 'modified Rankin Scale (mRS)', 'timeFrame': '90 (±14) days after treatment initiation', 'description': 'Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)'}], 'secondaryOutcomes': [{'measure': 'Disability-weighted (or utility-weighted) mRS', 'timeFrame': '90 (±14) days after treatment initiation', 'description': 'Standard utility weights applied to the mRS categories as follows: 1.0 for mRS level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6'}, {'measure': 'Return to the pre-stroke mRS level', 'timeFrame': '90 (±14) days after treatment initiation', 'description': 'Returning to the pre-stroke mRS level post stroke'}, {'measure': 'EQ-5D-5L', 'timeFrame': '90 (±14) days after treatment initiation', 'description': 'Quality of life assessment scale with range: 0 (worst health) to 100 (best health)'}, {'measure': 'Academic Medical Center - Linear Disability Scale (ALDS)', 'timeFrame': '90 (±14) days after treatment initiation', 'description': 'Generic item bank that measures the disability status of patients with a broad range of diseases, as expressed by the ability to perform activities in daily living.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Stroke, Acute', 'Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'TESTED will compare the risks and benefits of endovascular thrombectomy (EVT) to medical management (no EVT) in ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke.', 'detailedDescription': "People with disabilities can suffer acute ischemic stroke (AIS). Endovascular clot removal is a breakthrough therapy for large vessel occlusion (LVO) AIS. Pre-stroke disabled patients were excluded from pivotal EVT stroke trials, so whether EVT is effective for those with pre-stroke disability is not known. As a result, two competing, widely-practiced, treatment paradigms have emerged based on individual practitioners' extrapolation of EVT benefits and safety from patients without a pre-stroke disability to those with disability: 1) Multimodal Medical Management (MMM; using intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol lowering medications, and other rehabilitative measures, as indicated) without EVT, and 2) EVT with the background of MMM.\n\nTESTED will enroll patients with LVO-AIS who have a pre-existing disability, defined as pre-stroke modified Rankin score (mRS) 3 and 4, at 12 geographically distinct comprehensive stroke centers serving diverse race-ethnic and socioeconomic populations. The central objective of TESTED is to determine the comparative effectiveness and safety of these two different practice paradigms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke. They will be consented up to 72 hours after stroke onset in the acute hospitalization setting.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult patients (≥18 years)\n2. Moderate-to-severe pre-stroke functional disability, defined as mRS 3-4, for at least 3 months prior to stroke onset\n3. Presenting to study hospital within 24 hours of last known well time\n4. Diagnosis of acute ischemic stroke\n5. Intracranial causative occlusion of the internal carotid artery or the M1 or dominant M2 segments of the middle cerebral artery visualized on the baseline CT(or MR) angiogram\n6. Presenting CT Alberta Stroke Program Early CT (ASPECT) score ≥3 or MRI ASPECT score ≥4\n7. Presenting NIH Stroke Scale score ≥6\n8. Informed consent from patient if competent or from legally authorized representative\n\nExclusion Criteria:\n\n1. Known diagnosis of a terminal cancer or terminal illness at the time of stroke\n2. Assessment of pre-stroke functional status cannot be performed during the hospital stay\n3. Pre-stroke disability deemed temporary in the investigator's opinion (for example, recovering from a general medical illness or traumatic bodily injury)"}, 'identificationModule': {'nctId': 'NCT05911568', 'acronym': 'TESTED', 'briefTitle': 'Treatment With Endovascular Intervention for STroke Patients With Existing Disability', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Treatment With Endovascular Intervention for STroke Patients With Existing Disability', 'orgStudyIdInfo': {'id': '2023-0299'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke patients with moderate-to-severe pre-stroke disability', 'description': 'Patients with pre-stroke modified Rankin scale score 3 or 4, presenting with a anterior circulation large vessel occlusion stroke within 24 hours of last known well', 'interventionNames': ['Procedure: Endovascular Stroke Treatment', 'Other: Medical Management']}], 'interventions': [{'name': 'Endovascular Stroke Treatment', 'type': 'PROCEDURE', 'description': 'Patients who receive endovascular stroke treatment when they are admitted into the hospital, as determined by their clinical care team. Endovascular stroke treatment consist of catheter-based treatment for the blood clot causing the acute ischemic stroke', 'armGroupLabels': ['Stroke patients with moderate-to-severe pre-stroke disability']}, {'name': 'Medical Management', 'type': 'OTHER', 'description': 'Patients who receive MMM when they are admitted into the hospital, as determined by their clinical care team. MMM may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care. Specifically, this treatment does not involve endovascular stroke treatment.', 'armGroupLabels': ['Stroke patients with moderate-to-severe pre-stroke disability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashu Jadhav, MD', 'role': 'CONTACT'}, {'name': 'Ashu Jadhav, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HonorHealth', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shayandokht Taleb, MD', 'role': 'CONTACT'}, {'name': 'Shayandokht Taleb, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Saver, MD', 'role': 'CONTACT'}, {'name': 'Jeffrey Saver, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California at Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donald Frei, MD', 'role': 'CONTACT'}, {'name': 'Donald Frei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tapan Mehta, MD', 'role': 'CONTACT'}, {'name': 'Tapan Mehta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hartford Health Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adam DeHavenon, MD', 'role': 'CONTACT'}, {'name': 'Adam DeHavenon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Starke, MD', 'role': 'CONTACT'}, {'name': 'Robert Starke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Howard, MD', 'role': 'CONTACT'}, {'name': 'Brian Howard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mohamad AbdalKader, MD', 'role': 'CONTACT'}, {'name': 'Mohamad AbdalKader', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shahram Majidi, MD', 'role': 'CONTACT'}, {'name': 'Shahram Majidi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua Wiley, MD', 'role': 'CONTACT'}, {'name': 'Joshua Wiley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stacie Demel, DO, PhD', 'role': 'CONTACT'}, {'name': 'Stacie Demel, DO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amit Kansara, MD', 'role': 'CONTACT'}, {'name': 'Amit Kansara, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Providence St. Vincent Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raul Nogueira, MD', 'role': 'CONTACT'}, {'name': 'Raul Nogueira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Violiza Inoa, MD', 'role': 'CONTACT'}, {'name': 'Violiza Inoa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baptist Memorial Hospital', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Froehler, MD', 'role': 'CONTACT'}, {'name': 'Michael Froehler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Tirschwell, MD', 'role': 'CONTACT'}, {'name': 'David Tirschwell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ansaar Rai, MD', 'role': 'CONTACT'}, {'name': 'Ansaar Rai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'centralContacts': [{'name': 'Eva Mistry, MD', 'role': 'CONTACT', 'email': 'mistryea@ucmail.uc.edu', 'phone': '513-558-1291'}, {'name': 'Naima Griffin', 'role': 'CONTACT', 'email': 'griffna@ucmail.uc.edu', 'phone': '513-558-0125'}], 'overallOfficials': [{'name': 'Eva Mistry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}, {'name': 'Jeffrey Saver, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ronald Reagan UCLA Medical Center'}, {'name': 'J Mocco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Heidi Sucharew, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'One year after completing of the final analysis', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Eva A. Mistry', 'investigatorAffiliation': 'University of Cincinnati'}}}}