Safety and Efficacy of intra-arterial Tenecteplase for non-complete reperfusion of intracranial occlusio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

Informed consent, Age =18 years, Clinical signs consistent with an acute ischemic stroke, Patient had an initial large vessel occlusion in the anterior circulation defined as intracranial ICA, M1, M2, M3, A1, A2, P1 or P2, Patient has undergone endovascular stroke treatment, Onset to randomization no later than < 705 minutes (11h 45min) after symptom-onset/last-seen well., Incomplete reperfusion defined as any of the following: a. For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist). b. 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). c. Any emboli to the new territory without mechanically amendable target-occlusion (as per definition by the interventionalist)., 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)

Exclusion Criteria

Acute intracranial hemorrhage, Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma), Radiological confirmed evidence of cerebral vasculitis, Contraindication to MRI (e.g. pacemaker), Pregnancy or lactating women, 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, Intake of Vitamin K antagonista with INR >1.7, Platelets < 50,000, Non-controlled hypertension (defined as SBP >185 mmHg or DBP >110 mmHg refractory to treatment), Calcified thrombi, Active dyspeptic ulcer, Acute endocarditis, Known arterial aneurysm, Known neoplasms with risk of bleeding, Severe liver fibrosis or portal hypertension, Acute pericarditis, Acute pancreatitis, Known allergy to TNK or Gentamicin or other additives/auxiliaries (Polysorbatum 20, L-Argininum, Acidum phosphoricum), 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Efficacy And Safety of Injection Tenecteplase in 4.5 to 24 hours imaging Eligible Window patients with Acute Ischemic Stroke.

Not Applicable

Department of Science and Technology Science and Engineering Research Board Government of India

Updated 4/3/2023