2024-516544-26-00RecruitingPhase 2
Local Tenecteplase ApplicatiOn subsequent to endovasCular Recanalization in Anterior CircuLation Stroke - the LOCAL trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 20 Aug 2025
- Start date
- 30 Mar 2026
- Lead sponsor
- Universitaetsklinikum Heidelberg AöR
- Diseases
- Stroke
- EU CT number
- 2024-516544-26-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 380
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a sudden stroke caused by a blocked large artery in the front of the brain, whose artery was reopened successfully with a catheter procedure.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Acute ischemic stroke from a blocked large artery of the anterior circulation (distal ICA, Carotid-T, M1 or proximal M2), confirmed by CT or MRI and catheter angiography. Artery successfully reopened (eTICI≥ 2b50). Less than 24 hours since stroke onset or last seen well. NIHSS of 4 to 25 before the procedure. ASPECTS ≥ 6 on CT or ≥ 5 on diffusion weighted MRI.
- Earlier treatment
- Must have had mechanical recanalization (clot removal) with a successful result. Cannot have had intravenous rt-pA (alteplase) at the study site or intravenous TNK (tenecteplase) within 1 h before randomization.
Main reasons for not taking part
- Pre-stroke disability (before the stroke, mRS above 1)
- Bleeding in the brain now or before, or signs of it during the procedure
- Major surgery or severe bleeding in the past month
- Uncontrolled high blood pressure (SBP >185 mmHg or DBP >110 mmHg despite treatment)
- Pregnant or breast-feeding women
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- Thrombocytopenia (Platelet count < 100,000)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Aachen AöR | Aachen | Germany | Recruiting |
| Universitaetsklinikum Augsburg | Augsburg | Germany | Recruiting |
| Evangelisches Klinikum Bethel gGmbH | Bielefeld | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR | Bonn | Germany | Recruiting |
| Klinikum Dortmund gGmbH | Dortmund | Germany | Recruiting |
| HELIOS Klinikum Erfurt GmbH | Erfurt | Germany | Recruiting |
| Alfried Krupp Zentrum fuer Medizin und Rehabilitation gGmbH | Essen | Germany | Recruiting |
| DIAKO Krankenhaus gGmbH | Flensburg | Germany | Recruiting |
| Medical Center- University of Freiburg | Freiburg im Breisgau | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR | Heidelberg | Germany | Recruiting |
| RKH Klinken Ludwigsburg-Bietigheim gGmbH | Ludwigsburg | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz | Germany | Recruiting |
| Johannes Wesling Klinikum Minden | Minden | Germany | Recruiting |
| Klinikum Nuernberg | Nuremberg | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR | Wuerzburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.