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Local Tenecteplase ApplicatiOn subsequent to endovasCular Recanalization in Anterior CircuLation Stroke - the LOCAL trial
EU CTIS ID: 2024-516544-26-00
What this study is testing
To investigate whether supplementary intra-arterial administration of thrombolysis (Tenecteplase) after successful endovascular recanalization of anterior circulation ischemic stroke results in improved clinical outcome evaluated based on the proportion of patients with an excellent clinical outcome of mRS 0 – 1 after 90 days +/- 15 days
- Therapeutic exploratory (Phase II)
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
- Patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation (distal ICA, Carotid-T, M1 or proximal M2 occlusion) should be confirmed by either CT or MRI and must be proven by catheter angiographic run prior to mechanical recanalization.
- Successful recanalization (eTICI≥ 2b50) of intracranial artery occlusion (as per definition by the interventionalist).
- Estimated time between stroke onset / last seen well and study procedure of < 24 hours
- No relevant pre-stroke functional disability (pre-morbid mRS of 0 – 1)
- Neurological deficit with a NIHSS of ≥ 4 and ≤ 25 at baseline prior to thrombectomy
- Age ≥ 18
You likely can't join if
- Treatment with intravenous rt-pA (alteplase) thrombolysis at study site or intravenous TNK (tenecteplase) within 1 h before randomization
- Participating in another clinical trial that could confound the treatment or outcomes of this investigation
- Hypersensitivity to the active substance (Tenecteplase), to any other excipients or to gentamicin or know allergy against alteplase
- Pre-existing stenosis in the target vessel requiring stent therapy
- Tandem occlusions of both cervical and intracranial vessels
- Acute or prior intracranial hemorrhage or signs of intracranial hemorrhage during procedure
See the full eligibility criteria
- Patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation (distal ICA, Carotid-T, M1 or proximal M2 occlusion) should be confirmed by either CT or MRI and must be proven by catheter angiographic run prior to mechanical recanalization.
- Successful recanalization (eTICI≥ 2b50) of intracranial artery occlusion (as per definition by the interventionalist).
- Estimated time between stroke onset / last seen well and study procedure of < 24 hours
- No relevant pre-stroke functional disability (pre-morbid mRS of 0 – 1)
- Neurological deficit with a NIHSS of ≥ 4 and ≤ 25 at baseline prior to thrombectomy
- Age ≥ 18
- ASPECTS ≥ 6 on baseline non-contrast CT or ASPECTS ≥ 5 on diffusion weighted MRI
- Treatment with intravenous rt-pA (alteplase) thrombolysis at study site or intravenous TNK (tenecteplase) within 1 h before randomization
- Participating in another clinical trial that could confound the treatment or outcomes of this investigation
- Hypersensitivity to the active substance (Tenecteplase), to any other excipients or to gentamicin or know allergy against alteplase
- Pre-existing stenosis in the target vessel requiring stent therapy
- Tandem occlusions of both cervical and intracranial vessels
- Acute or prior intracranial hemorrhage or signs of intracranial hemorrhage during procedure
- Any efforts to control non-controlled hypertension after thrombectomy and before trial inclusion exceed 10 minutes
- Notably increased risk of intracranial hemorrhage
- Dissection of the extra- or intracranial cerebral arteries
- Major surgery or any severe bleeding in the past month
- Thrombocytopenia (Platelet count < 100,000)
- Insufficient command of the German language, if this can be reliably determined prior to enrolment.
- Non-controlled hypertension (defined as SBP >185 mmHg or DBP >110 mmHg refractory to treatment)
- Pregnant or breast-feeding women
- Known severe illness with life expectancy less than 12 months
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.