Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-06 @ 12:13 AM
Study NCT ID:
NCT04202458
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2019-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-21', 'studyFirstSubmitDate': '2019-12-15', 'studyFirstSubmitQcDate': '2019-12-15', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'incidence of symptomatic intracranial haemorrhage', 'timeFrame': '48 hours', 'description': 'more than 4 increase in NIHSS caused by intracranial bleeding'}], 'primaryOutcomes': [{'measure': 'Proportion of sufficient recanalization', 'timeFrame': 'Immediately after TNK treatment', 'description': 'sufficient recanalization is defined as TICI 2b-3'}], 'secondaryOutcomes': [{'measure': 'Proportion of favorable outcome', 'timeFrame': '90 days', 'description': 'favorable outcome is defined as mRS 0-2'}, {'measure': 'proportion of early neurological improvement', 'timeFrame': '48 hours', 'description': 'early neurological improvement is defined as more than 4 decrease in NIHSS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '37143999', 'type': 'DERIVED', 'citation': 'Zhao ZA, Qiu J, Wang L, Zhao YG, Sun XH, Li W, Liu X, Li XL, Liu L, Chen MR, Chen HS. Intra-arterial tenecteplase is safe and may improve the first-pass recanalization for acute ischemic stroke with large-artery atherosclerosis: the BRETIS-TNK trial. Front Neurol. 2023 Apr 18;14:1155269. doi: 10.3389/fneur.2023.1155269. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': "Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. However, sufficient recanalization (mTICI2b-3) can 't be acquired in all patients under thrombectomy. The EXTEND-IA TNK study indicated that tenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase among patients with ischemic stroke treated within 4.5 hours after symptom onset. This study intends to explore whether a combination of thrombectomy and intra-arterial TNK administration can increase recanalization rate after the first attempt of thrombectomy device pass for ischemic Stroke."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;\n3. The subtype of ischemic stroke is large-artery atherosclerosis according to TOAST classification;\n4. The availability of informed consent.\n\nExclusion Criteria:\n\n1. Other sub-types of ischemic stroke such as cardioembolism.\n2. Hemorrhagic stroke such as cerebral hemorrhage, subarachnoid hemorrhage.\n3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\\<100000/mm3).\n4. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis.\n5. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).\n6. Patients allergic to any ingredient of drugs in our study.\n7. Unsuitable for this clinical studies assessed by researcher.'}, 'identificationModule': {'nctId': 'NCT04202458', 'briefTitle': 'Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK)', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK): a Prospective, Random, Pilot Study', 'orgStudyIdInfo': {'id': 'k(2019)29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intra-arterial tenecteplase administration', 'description': 'Intra-arterial administration of 4mg tenecteplase is given after microcatheter navigation through the clot. Intra-arterial administration of tenecteplase (0.4 mg/min) continuously is given after the first attempt of thrombectomy device pass for 30 minutes, and then followed by DSA', 'interventionNames': ['Drug: intra-arterial tenecteplase administration']}], 'interventions': [{'name': 'intra-arterial tenecteplase administration', 'type': 'DRUG', 'description': 'Intra-arterial administration of 4mg tenecteplase is given after microcatheter navigation through the clot. Intra-arterial administration of tenecteplase (0.4 mg/min) continuously is given after the first attempt of thrombectomy device pass for 30 minutes, and then followed by DSA.', 'armGroupLabels': ['intra-arterial tenecteplase administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110840', 'city': 'Shenyang', 'country': 'China', 'facility': 'General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hui-Sheng Chen', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}