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