Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT05499832
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2022-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': 'D000077785', 'term': 'Tenecteplase'}], 'ancestors': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2022-08-11', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early reperfusion of the residual intracranial occlusion(s)', 'timeFrame': '25 minutes after randomization', 'description': 'Defined by reperfusion improvement on angiography images'}, {'measure': 'Late reperfusion of the residual intracranial occlusion(s)', 'timeFrame': '24 hours ±6 hours', 'description': 'Defined by complete reperfusion on perfusion imaging'}], 'secondaryOutcomes': [{'measure': 'Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis)', 'timeFrame': '90 days+/-15 days', 'description': 'mRS'}, {'measure': 'Normalized change in National Institute of Health Score Scale (NIHSS)', 'timeFrame': '24 hours +/- 6 hours post-randomization', 'description': 'NIHSS'}, {'measure': 'Change in National Institute of Health Score Scale (NIHSS)', 'timeFrame': '90 days +/- 15 days post-randomization', 'description': 'NIHSS'}, {'measure': 'Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L)', 'timeFrame': '90 days +/- 15 days', 'description': 'EuroQol 5D-3L'}, {'measure': 'All-cause mortality', 'timeFrame': '90 days', 'description': 'Mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '39567366', 'type': 'DERIVED', 'citation': 'Mujanovic A, Windecker D, Cimflova P, Meinel TR, Seiffge DJ, Auer E, Boulouis G, Arnold M, Serrallach BL, Rohner R, Janot K, Dobrocky T, Hill MD, Goyal M, Piechowiak EI, Gralla J, Fischer U, Kaesmacher J. Natural Evolution of Incomplete Reperfusion in Patients Following Endovascular Therapy After Ischemic Stroke. Stroke. 2025 Feb;56(2):447-455. doi: 10.1161/STROKEAHA.124.049641. Epub 2024 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'TECNO is a multicenter, prospective, randomized, open label, blinded endpoint (PROBE) proof-of-concept trial evaluating if additional administration of intra-arterial Tenecteplase (TNK) improves reperfusion in patients with incomplete mechanical thrombectomy (MT). For this purpose, 156 adult participants experiencing an acute ischemic stroke due to a large vessel occlusion with incomplete reperfusion with residual occlusions after MT will be randomly assigned to receive 3mg intra-arterial (IA) TNK or best medical treatment. Recruitment will occur at 20 academic tertiary stroke care centers in Switzerland, Spain, Belgium, and Germany and patients are followed up for 90 days after the index event. Showing superiority for reperfusion outcomes would have a major impact on the future management of stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Informed consent\n* Age ≥18 years\n* Clinical signs consistent with an acute ischemic stroke\n* Patient had an initial vessel occlusion in the anterior or posterior circulation defined as intracranial ICA, M1, M2, M3, A1, A2, P1 or P2\n* Patient has undergone endovascular stroke treatment\n* Onset to randomization no later than \\< 705 minutes (11h 45min) after symptom-onset/last-seen well.\n* Incomplete reperfusion defined as any of the following:\n\n 1. For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).\n 2. For A1/A2, P1/P2, M2/M3: TICI2a/2b/2c (1-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).\n 3. Any emboli to new territory without mechanically amendable target-occlusion (as per definition by the interventionalist).\n* Signs of early ischemic changes of non-contrast CT Alberta Stroke Program Early CT Score (ASPECTS) ≥5 (for DWI-ASPECTS ≥ 4, for DWI-ASECTS: a region must have diffusion abnormality in 20% or more of its volume to be considered DWI-ASPECTS positive)\n\nExclusion Criteria\n\n* Acute intracranial hemorrhage\n* Contraindication to MRI (e.g. pacemaker)\n* Any severe bleeding within the past 6 months, which would prevent administration of intravenous thrombolysis in clinical routine Major surgery in the past 2 months with severe risk of bleeding, which would prevent administration of intravenous thrombolysis in clinical routine\n* Intake of Vitamin K antagonists with INR \\>1.7\n* Platelets \\< 50,000\n* Non-controlled hypertension (defined as SBP \\>185 mmHg or DBP \\>110 mmHg refractory to treatment)\n* Active dyspeptic ulcer\n* Known arterial aneurysm\n* Known neoplasms with risk of bleeding\n* Severe liver fibrosis or portal hypertension\n* Acute pericarditis\n* Acute endocarditis\n* Acute pancreatitis\n* Known allergy to TNK or Gentamicin or other additives/auxiliaries (Polysorbatum 20, L-Argininum, Acidum phosphoricum)\n* Known Renal failure either as defined by a serum creatinine \\> 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \\[GFR\\] \\< 30 or as subject who required hemodialysis/peritoneal dialysis\n* Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)\n* Radiological confirmed evidence of cerebral vasculitis\n* Calcified thrombi\n* Pregnancy or lactating women'}, 'identificationModule': {'nctId': 'NCT05499832', 'acronym': 'TECNO', 'briefTitle': 'Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions', 'orgStudyIdInfo': {'id': '2022-00388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Best Medical Treatment (standard of care)', 'description': 'Patients will receive standard of care as per current ESO guidelines.'}, {'type': 'EXPERIMENTAL', 'label': 'Intra-arterial Tenecteplase', 'description': 'Patients will receive intra-arterial administration of Tenecteplase using a standard approved microcatheter.', 'interventionNames': ['Drug: Tenecteplase']}], 'interventions': [{'name': 'Tenecteplase', 'type': 'DRUG', 'description': 'Patients randomized to IA treatment will receive IA TNK via a standard approved microcatheter positioned as close as possible to the residual occlusion site or as distal as possible in the originating vessel if multiple residual occlusions exists.', 'armGroupLabels': ['Intra-arterial Tenecteplase']}]}, 'contactsLocationsModule': 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'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Clinique CHC MontLégia', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'University Hospital Helsinki', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '28205', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinikum Bremen-Mitte', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '99089', 'city': 'Erfurt', 'country': 'Germany', 'facility': 'Helios Klinikum Erfurt', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '60528', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Universitätsmedizin 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