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

Insel Gruppe AG, University Hospital Bern

Status and phase

Active, not recruiting

Phase 3

Conditions

Ischemic Stroke

Treatments

Drug: Tenecteplase

Study type

Interventional

Funder types

Other

Identifiers

NCT05499832

2022-00388

Details and patient eligibility

About

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.

Enrollment

156 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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