Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-01-06 @ 8:53 PM
Study NCT ID:
NCT05172934
Status:
COMPLETED
Last Update Posted:
2025-03-21
First Post:
2021-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-23', 'mcpReleaseN': 4, 'releaseDate': '2025-09-03'}], 'estimatedResultsFirstSubmitDate': '2025-09-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will receive intra-arterial Tenecteplase after achieving mTICI 2b or 2c reperfusion with standard of care mechanical thrombectomy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2021-12-28', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of any intracranial hemorrhage and neurologic worsening', 'timeFrame': '24 hours post-treatment with intra-arterial Tenecteplase', 'description': 'Incidence of any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS), according to the European Cooperative Acute Stroke Study II (ECASS-II) criteria, within 24 hours of treatment with IA TNK'}], 'secondaryOutcomes': [{'measure': 'Improved reperfusion', 'timeFrame': 'immediate post-treatment', 'description': 'Proportion of patients with improved reperfusion (mTICI 2c/3) at end of IA treatment'}, {'measure': 'Improved reperfusion', 'timeFrame': 'immediate post-treatment', 'description': 'Proportion of patients with improvement of reperfusion to mTICI 2c, mTICI 3, and mTICI 2c-3.'}, {'measure': 'Ordinal modified Rankin Scale Score', 'timeFrame': '90 days post-treatment', 'description': 'Ordinal modified Rankin Scale Score at 90 days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).'}, {'measure': 'Functional Independence', 'timeFrame': '90 days post-treatment', 'description': 'Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days'}, {'measure': 'Final revascularization grade', 'timeFrame': 'immediate post-treatment', 'description': 'Final revascularization grade at end of IA treatment using the modified Thrombolysis in Cerebral Infarction (mTICI) grading scale.'}, {'measure': 'Mortality', 'timeFrame': 'Hospital Discharge (Day 6 post-randomization (+/- 1 day))', 'description': 'Mortality rate at discharge'}, {'measure': 'Asymptomatic intracranial hemorrhage', 'timeFrame': '24 hours post-treatment', 'description': 'Incidence of any asymptomatic intracranial hemorrhage'}, {'measure': 'Mean number of boluses', 'timeFrame': 'Immediate post-procedure', 'description': 'Mean number of boluses to achieve improvement in reperfusion to mTICI 2c and mTICI 3'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thrombolytic', 'stroke', 'distal emboli'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '39772606', 'type': 'DERIVED', 'citation': 'Zaidi SF, Castonguay AC, Zaidat OO, Jadhav AP, Sheth SA, Haussen DC, Nguyen TN, Burgess RE, Alhajala HS, Gharaibeh K, Salahuddin H, Rao R, Oliver MJ, Jumaa MA. Safety of Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy: The ALLY Pilot Trial. Stroke. 2025 Feb;56(2):355-361. doi: 10.1161/STROKEAHA.124.048846. Epub 2025 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, single center, non-randomized, pilot study to assess the feasibility of IA TNK following standard of care mechanical thrombectomy (MT) in patients with AIS. Participants will receive IA TNK after achieving mTICI 2b or 2c reperfusion with standard of care MT. Patients enrolled into the study will be followed for 3 months after treatment with IA TNK.', 'detailedDescription': 'As current MT technology is not amenable to retrieval of distal occlusions (M3/M4, etc), we hypothesize that IA lytic may play an important role as an adjunctive therapy to open up distal vessels (after the primary LVO has been removed) to achieve complete or near complete reperfusion. In this pilot trial, our goal is to assess the feasibility and safety of IA Tenecteplase (TNK) as an adjunctive therapy following standard of care mechanical thrombectomy (MT) in patients with AIS. A total of 20 patients will be enrolled into the ALLY pilot study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Age 18-85\n* 2\\. Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well\n* 3\\. a. Patients treated less than 6 hours since last known well with ASPECTS \\>6. b. Patients treated beyond 6 hours since last known well, CT or MRI perfusion scan showing favorable mismatch profile (Target mismatch profile on CT perfusion or MRI (ischemic core volume is \\<70ml, mismatch ratio is \\>1.8 and mismatch volume is \\>15ml)\n* 4\\. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or 2c with persistent occlusion(s) in terminal branches not amenable to MT.\n* 5\\. Signed informed consent\n\nExclusion Criteria:\n\n* 1\\. Premorbid modified Rankin scale (mRS) score of 4 or greater\n* 2\\. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT\n* 3\\. Platelet count \\<100,000\n* 4\\. Known bleeding diathesis\n* 5\\. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency\n* 6\\. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \\>1.8\n* 7\\. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)\n* 8\\. Pregnant or lactating\n* 9\\. Previous known allergy to TNK\n* 10\\. Major surgery in past 30 days\n* 11\\. Patient is on or requires dialysis\n* 12\\. History of intracranial hemorrhage or serious head trauma at any time\n* 13\\. Any condition in the opinion of the enrolling physician that would preclude the patient from participating\n* 14\\. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation\n* 15\\. Severe, uncontrolled hypertension (systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg) that is refractory to treatment\n* 16\\. History of acute ischemic stroke in the last 60 days\n* 17\\. Presumed septic embolus; suspicion of bacterial endocarditis\n* 18\\. Suspicion of aortic dissection\n* 19\\. Intracranial neoplasm\n* 20\\. Any mass effect\n* 21\\. Any terminal medical condition with life expectancy less than 6 months\n* 22\\. Concurrent enrollment in another trial that could confound the results of this study'}, 'identificationModule': {'nctId': 'NCT05172934', 'acronym': 'ALLY', 'briefTitle': 'Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'ProMedica Health System'}, 'officialTitle': 'Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial', 'orgStudyIdInfo': {'id': 'ALLY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-arterial Tenecteplase', 'description': 'Participants will receive intra-arterial Tenecteplase after achieving mTICI 2b or 2c reperfusion with standard of care MT.', 'interventionNames': ['Drug: intra-arterial tenecteplase']}], 'interventions': [{'name': 'intra-arterial tenecteplase', 'type': 'DRUG', 'description': 'intra-arterial drug administered after mechanical thrombectomy', 'armGroupLabels': ['Intra-arterial Tenecteplase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProMedica Toledo Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Syed F Zaidi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ProMedica Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProMedica Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}