Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions

Más betegség

• Acute intracranial hemorrhage
• 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
• Non-controlled hypertension (defined as SBP \>185 mmHg or DBP \>110 mmHg refractory to treatment)
• Active dyspeptic ulcer
• Known neoplasms with risk of bleeding
• Severe liver fibrosis or portal hypertension
• Known allergy to TNK or Gentamicin or other additives/auxiliaries (Polysorbatum 20, L-Argininum, Acidum phosphoricum)

Laborértékek

• Intake of Vitamin K antagonists with INR \>1.7
• Platelets \< 50,000
• 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

Egyéb

• Contraindication to MRI (e.g. pacemaker)
• Known arterial aneurysm
• Acute pericarditis
• Acute endocarditis
• Acute pancreatitis
• Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
• Radiological confirmed evidence of cerebral vasculitis
• Calcified thrombi
• Pregnancy or lactating women

• Informed consent
• Age ≥18 years
• Clinical signs consistent with an acute ischemic stroke
• Patient had an initial vessel occlusion in the anterior or posterior 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:
  • For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).
  • 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).
  • Any emboli to 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)