Tenecteplase Injected Into the Artery for Stroke From a Medium Vessel Blockage
Tests tenecteplase given into the artery in adults with stroke from a medium vessel blockage.
Plain-language title generated from the registry record
Registry title: Intra-arterial Recombinant Human Tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for Acute Medium Vessel Occlusion
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. 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 who had a stroke from a blocked medium-sized brain artery in the last 24 hours, to test a clot-dissolving drug given through an artery.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Stroke caused by a blocked medium or distal brain artery, seen on CT or MR angiography, within 24 hours of onset. Symptoms must be clearly disabling or NIHSS score ≥4. Some people in the 6-24 hour window need specific brain scan findings.
- Earlier treatment
- Before the stroke, daily function was normal or nearly normal (mRS score 0-1). People who had severe head injury or stroke in the past 3 months, or surgery or biopsy of an organ in the past 30 days, cannot join.
Main reasons for not taking part
- Bleeding inside the skull or any active bleeding
- Blood pressure that stays too high (systolic >185 mmHg or diastolic >110 mmHg)
- A tendency to bleed, or on blood thinners with INR >1.7
- Severe liver or kidney problems, or long-term haemodialysis
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Where in China
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Xiang LuoTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xiang Luo
- Trial code
- NCT07302854
- Record updated
- 21 January 2026
- Original description
Medium vessel occlusion (MeVO) accounts for 20-45% of acute ischemic stroke (AIS). Although patients with MeVO often present with relatively low NIHSS scores, up to one-third remain functionally dependent at follow-up despite receiving standard medical therapy, including intravenous thrombolysis. Recent randomized trials (DISTAL, ESCAPE-MeVO, DISCOUNT) have not demonstrated clinical benefit of endovascular treatment (EVT) for MeVO and have suggested higher risks of symptomatic intracranial hemorrhage and mortality, underscoring the need for safer and more targeted reperfusion strategies.Read full original descriptionShow less
Intra-arterial Recombinant Human Tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for Acute Medium Vessel Occlusion -- A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Trial
Medium vessel occlusion (MeVO) accounts for 20-45% of acute ischemic stroke (AIS). Although patients with MeVO often present with relatively low NIHSS scores, up to one-third remain functionally dependent at follow-up despite receiving standard medical therapy, including intravenous thrombolysis. Recent randomized trials (DISTAL, ESCAPE-MeVO, DISCOUNT) have not demonstrated clinical benefit of endovascular treatment (EVT) for MeVO and have suggested higher risks of symptomatic intracranial hemorrhage and mortality, underscoring the need for safer and more targeted reperfusion strategies.
Intra-arterial thrombolysis (IAT) enables localized, high-concentration thrombolytic delivery with minimal mechanical manipulation, which may be advantageous for medium and distal vessels. Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA), a genetically engineered third-generation thrombolytic agent, has shown favorable pharmacologic properties and clinical safety in AIS, including in intra-arterial use following EVT. However, prospective evidence supporting its direct therapeutic role in MeVO-related AIS remains lacking.
This multicenter, prospective, open-label randomized controlled trial with blinded endpoint assessment is designed to evaluate the efficacy and safety of intra-arterial rhTNK-tPA thrombolysis in improving functional outcome in MeVO within 24 hours of symptom onset.
Inclusion: Age ≥18 years; Pre-stroke mRS score 0-1; Baseline NIHSS ≥4 or symptoms deemed clearly disabling by treating physician (e.g., hemianopia, aphasia, or motor dysfunction); Isolated medium distal vessel occlusion (i.e., an occlusion of the co-/non-dominant M2, the M3/M4 segment of the MCA, the A1/A2/A3 segment of the ACA or the P1/P2/P3 segment of the PCA) confirmed by CT angiography (CTA) or MR angiography (MRA); Acute ischemic stroke within 24 hours of symptom onset, including wake-up stroke or unwitnessed stroke; The onset time of symptoms was defined as the last time of normal performance; Acute ischemic stroke within 6-24 hours of onset, meeting at least one of the following imaging criteria:; Evidence of a hypoperfusion-ischemic core mismatch on CT or MRI perfusion, defined as an ischemic core volume <50mL, hypoperfused tissue volume to ischemic core volume ratio ≥1.2, and mismatch volume ≥10 mL; Evidence of a diffusion-hyperintensity mismatch, defined as absence of hyperintensity on fluidattenuated inversion recovery (FLAIR) imaging within ≥ 90% of the area of the diffusion weighted imaging (DWI) lesion); The participant or legally authorized representative is capable of providing informed consent.
Exclusion: Any active bleeding (gastrointestinal, urinary, hemorrhagic retinopathy, etc.) or parenchymal organ surgery or biopsy within 30 days before stroke; Severe head trauma or stroke within the past 3 months; Evidence of intracranial hemorrhage; Persistent and uncontrolled hypertension, defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg; Allergy to rhTNK-tPA or radiocontrast agent; Expected survival time less than 6 months (e.g., due to malignancy, severe cardiopulmonary disease, etc.); Other conditions deemed by the investigator to make the patient unsuitable for participation or pose significant risks (e.g., inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders); Inherited or acquired hemorrhagic tendancy; deficiency of anticoagulant factors; or on oral anticoagulant with an INR> 1.7; Blood glucose <2.8 mmol/L (50 mg/dl) or > 22.2mmol/L (400 mg/dl), platelets count <100*109/L, or hemoglobin <70g/L; Severe hepatic insufficiency, chronic hemodialysis and severe renal insufficiency (or recent blood tests suggesting a glomerular filtration rate <30 ml/min or blood creatinine> 200 mmol/L (2.5 mg/dl); Women who are pregnant or breastfeeding; Participation in other clinical trials.