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

Inclusion Criteria

• 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:

1. For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).

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).

3. 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)

Exclusion Criteria

• Acute intracranial hemorrhage

• Contraindication to MRI (e.g. pacemaker)

• 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 antagonists with INR >1.7

• Platelets < 50,000

• Non-controlled hypertension (defined as SBP >185 mmHg or DBP >110 mmHg refractory to treatment)

• Active dyspeptic ulcer

• Known arterial aneurysm

• Known neoplasms with risk of bleeding

• Severe liver fibrosis or portal hypertension

• Acute pericarditis

• Acute endocarditis

• 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

• Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)

• Radiological confirmed evidence of cerebral vasculitis

• Calcified thrombi

• Pregnancy or lactating women