Local Tenecteplase ApplicatiOn subsequent to endovasCular Recanalization in Anterior CircuLation Stroke - the LOCAL trial
Key facts
- Where
- Aachen, Augsburg, Bielefeld, Bonn, Dortmund, Erfurt, Essen, Flensburg, Freiburg im Breisgau, Heidelberg, Ludwigsburg, Mainz, Minden, Nuremberg és Wuerzburg, NémetországSee the 15 sites
- Phase
- 2. fázis
Where in Németország
- Universitaetsklinikum Aachen AöRAachen, NémetországTaking people
- Universitaetsklinikum AugsburgAugsburg, NémetországTaking people
- Evangelisches Klinikum Bethel gGmbHBielefeld, NémetországTaking people
- Universitaetsklinikum Bonn AöRBonn, NémetországTaking people
- Klinikum Dortmund gGmbHDortmund, NémetországTaking people
- HELIOS Klinikum Erfurt GmbHErfurt, NémetországTaking people
- Alfried Krupp Zentrum fuer Medizin und Rehabilitation gGmbHEssen, NémetországTaking people
- DIAKO Krankenhaus gGmbHFlensburg, NémetországTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, NémetországTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, NémetországTaking people
- RKH Klinken Ludwigsburg-Bietigheim gGmbHLudwigsburg, NémetországTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, NémetországTaking people
- Johannes Wesling Klinikum MindenMinden, NémetországTaking people
- Klinikum NuernbergNuremberg, NémetországTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaetsklinikum Heidelberg AöR
- Trial code
- EU 2024-516544-26-00
- Record updated
- 2026. október 8.
- Original description
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 daysRead full original descriptionShow less
Local tenecteplase applicatiOn subsequent to endovasCular recanalization in Anterior circuLation stroke - the LOCAL trial
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
Inclusion: 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.
Exclusion: Treatment with intravenous rt-pA (alteplase) thrombolysis at study site or intravenous TNK (tenecteplase) within 1 h before randomization; Pre-existing stenosis in the target vessel requiring stent therapy; Acute or prior intracranial hemorrhage or signs of intracranial hemorrhage during procedure; Insufficient command of the German language, if this can be reliably determined prior to enrolment; Hypersensitivity to the active substance (Tenecteplase), to any other excipients or to gentamicin or know allergy against alteplase; Any efforts to control non-controlled hypertension after thrombectomy and before trial inclusion exceed 10 minutes; Notably increased risk of intracranial hemorrhage; Major surgery or any severe bleeding in the past month; Non-controlled hypertension (defined as SBP >185 mmHg or DBP >110 mmHg refractory to treatment); Known severe illness with life expectancy less than 12 months; Thrombocytopenia (Platelet count < 100,000); Participating in another clinical trial that could confound the treatment or outcomes of this investigation; Tandem occlusions of both cervical and intracranial vessels; Dissection of the extra- or intracranial cerebral arteries; Pregnant or breast-feeding women.