Can a Clot-Removing procedure beat standard care for brain vein blockage?

NCT ID NCT06583889

Running, but no longer taking on new participants.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests whether a procedure to remove blood clots from veins in the brain works better than standard blood-thinning medication for people with cerebral venous sinus thrombosis (CVST), a rare type of stroke. Participants will be randomly assigned to receive either the endovascular procedure or standard heparin therapy. The study will measure how many people achieve a good recovery after three months, including improvements in headaches, vision, and daily function.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Endovascular treatment (mechanical thrombectomy, balloon angioplasty, local alteplase or urokinase) compared with standard medical care (heparin)
What this could lead to
If successful, this could establish endovascular treatment as a better option for certain CVST patients, potentially reducing disability and improving recovery.
What could go wrong
The trial is still testing this approach, and endovascular treatment carries risks like bleeding in the brain. Results may not apply to all patients.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: General inclusion criteria 1. age between 18 years and 60 years 2. Cerebral venous sinus thrombosis (CVST), confirmed by computed tomographic and magnetic resonance imaging (T1, T2, SWI, DWI, FLAIR), magnetic resonance venography, computed tomographic venography or digital subtraction angiography. 3. Patients with CVST who meet the following conditions (1) Within 3 weeks of acute onset (2) There are one of the obvious clinical symptoms: A. symptoms of intracranial hypertension: headache, papilledema, visual acuity and visual field damage; B. Neurological impairment symptoms; C. Seizure; D. Disturbance of consciousness (GCS score≥9) 4. Lumbar puncture pressure≥250mmH2O 5. Patients or their relatives can sign written informed consent Image inclusion criteria 1.CT and MRI (T1, T2, MRV, SWI, DWI) are used to screen CVST as acute phase (T1 low signal, T2 equal signal or slightly high signal; CT showed that the corresponding area is high signal) or subacute phase (T1 and T2 high signal) 2.3D-TOF or CE-MRA or CTV are used to screen the types of venous sinus thrombosis occlusion of main drainage which is prone to intracranial hypertension due to venous sinus thrombosis as follows: A.Superior sagittal sinus occlusion: thrombus obliterates the posterior 1/2 segment of superior sagittal sinus B.Transverse sinus occlusive type: 1. complete thrombosis of the bilateral transverse sinus with or without the corresponding sigmoid sinus involvement 2. complete thrombosis of the superior transverse sinus with or without the corresponding sigmoid sinus involvement C.complete thrombosis of the superior sagittal sinus and unilateral transverse sinus with or without the corresponding sigmoid sinus involvement D.complete thrombosis of the superior sagittal sinus and bilateral transverse sinus with the corresponding sigmoid sinus is occluded Exclusion Criteria: 1. Received any thrombolytic therapy within 7 days 2. Patients who cannot cooperate or accept MRI examination 3. Patients with dementia or mental illness are known to be unable to complete neurological function assessment and follow-up 4. Patients with high myopia and eye diseases affecting fundus examination and visual field examination 5. The patient has a clear history of primary headache such as migraine, tension headache and cluster headache, and a clear history of secondary headache 6. Patients who receive major surgery (excluding lumbar puncture) or a history of severe brain injury within 2 weeks 7. Known history of severe allergy to contrast media (excluding rash) 8. Gastrointestinal bleeding occurred within 3 months (excluding bleeding from recto anal hemorrhoids) 9. Serious liver function or renal dysfunction with written records and affecting normal coagulation function 10. Hemorrhagic disease (hemorrhagic disease history) with written records 11. Excepting for CVST, patients with any life expectancy less than 1 year (such as advanced cancer) 12. Pregnant women (puerperal women can be enrolled) 13. Patients with contraindications to anticoagulation or thrombolysis 14. Intracranial infectious or malignant tumor secondary to cerebrospinal fluid 15. CVST secondary to autoimmune diseases and hematological diseases (such as primary thrombocytosis, myelodysplastic syndrome, leukemia, etc.) and genetic factors 16. Concurrent thrombocytopenia (\<100×109/L) 17. MRI features showed that the occluded vessels of venous sinus were in chronic phase (T1 and T2 images showed equal signal) 18. Severe brain tissue injury symptoms such as obvious space occupying effect due to massive cerebral edema, cerebral infarction or cerebral hemorrhage 19. Patients with CVST accompanied by ventricular compression and hydrocephalus requiring surgery 20. Participating in clinical trials of any other drugs or medical devices, or may participate in clinical trials of any other drugs or medical devices within 6 months after being enrolled in this clinical trial 21. The researchers judge that there are other situations that are not suitable for enrollment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100010, China

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