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

• Status: Not yet recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Tenecteplase

Criteria

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 or M2.

• Patient has undergone endovascular stroke treatment

• Onset to randomization no later than < 345 minutes after symptom-onset/last-seen well.

• Incomplete reperfusion defined as

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 M2: TICI2a/2b/2c (1-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).

3. ICA/M1/M2 with TICI3 reperfusion (MCA territory) but emboli to the ACA 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)

• Patients with both, anterior and middle cerebral artery embolizations during the procedure

• Tandem occlusion requiring cervical stenting

• Any severe bleeding within the past 6 months

• Major surgery in the past 2 months

• Intake of direct oral anticoagulants <12h or Vitamin K Antagonist with INR >1.3

• Platelets < 50,000

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