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Safety and Efficacy of intra-arterial Tenecteplase for non-complete reperfusion of intracranial occlusion
EU CTIS ID: 2022-502878-16-00
What this study is testing
The primary objective of this trial is to determine the safety and efficacy of intra-arterial Tenecteplase in patients experiencing an acute ischemic stroke due to a large vessel occlusion with incomplete reperfusion with residual occlusions after mechanical thrombectomy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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, 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.
You likely can't join if
- Acute intracranial hemorrhage
- Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
- Radiological confirmed evidence of cerebral vasculitis
- Contraindication to MRI (e.g. pacemaker)
- Pregnancy or lactating women
- Any severe bleeding within the past 6 months, which would prevent administration of intravenous thrombolysis in clinical routine
See the full eligibility 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, 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: a. For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist). b. 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). c. Any emboli to the 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)
- Acute intracranial hemorrhage
- Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
- Radiological confirmed evidence of cerebral vasculitis
- Contraindication to MRI (e.g. pacemaker)
- Pregnancy or lactating women
- 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 antagonista with INR >1.7
- Platelets < 50,000
- Non-controlled hypertension (defined as SBP >185 mmHg or DBP >110 mmHg refractory to treatment)
- Calcified thrombi
- Active dyspeptic ulcer
- Acute endocarditis
- Known arterial aneurysm
- Known neoplasms with risk of bleeding
- Severe liver fibrosis or portal hypertension
- Acute pericarditis
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.