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Tests clot removal in stroke patients treated more than a day after symptoms

Tests a procedure to remove blood clots in adults with large artery stroke.

Key facts

Who runs it
Tianjin Huanhu Hospital
Where
Tianjin, ChinaSee the site
Trial code
Registry title
Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography
Status
Recruiting
People taking part
350 people, planned
Started
25 Jun 2024
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Endovascular Thrombectomy
Record updated
23 October 2024

Who can take part

AI summary

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 caused by a blocked large brain artery and can start thrombectomy 24 to 72 hours after the stroke began.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Blocked ICA or MCA-M1 artery seen on MRA or CTA, with moderate to good collateral blood flow on CTA. NIHSS score of 2 or more, before the study starts and just before randomization.
Earlier treatment
No significant disability before the stroke (modified Rankin Scale score of 0-2). Thrombectomy must be able to start within 24 to 72 hours of the stroke onset. People given tPA more than 4.5 hours after last known well, or who had clot retrieval within 24 hours of symptom onset, cannot join.

Main reasons for not taking part

  • Serious, advanced or terminal illness, or life expectancy under six months
  • Pregnancy
  • Bleeding disorder, or INR above 3 after recent oral anticoagulant treatment
  • Blood glucose under 50mg/dL (2.8 mmol/L) or over 400mg/dL (22.2 mmol/L), or platelet count under 50,000/uL
  • Severe hypertension that medicines cannot treat (systolic over 185 mmHg or diastolic over 110 mmHg)

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Confirmation of ICA or MCA-M1 occlusion, as detected by MRA or CTA, with carotid occlusions potentially occurring in either the cervical or intracranial regions, and the possibility of accompanying tandem MCA lesions
  • Demonstration of moderate to good collateral flow, as evidenced by CTA imaging
  • The patient must be aged 18 years or older
  • The baseline NIHSSS score is equal to or greater than 2, and this score remains equal to or greater than 2 immediately prior to randomization
  • Endovascular treatment can be initiated (via femoral puncture) within a window of 24 to 72 hours from the onset of the stroke. The onset of the stroke is defined as the time the patient was last known to be at their neurologic baseline (patients with wake-up strokes are eligible if they meet the aforementioned time constraints)
  • There must be no significant pre-stroke disability, as indicated by a pre-baseline modified Rankin Scale score of 0-2
  • The patient must be willing and able to return for the protocol-required follow-up visits
  • The patient or their legally authorized representative must have signed the Informed Consent form

Who cannot take part

  • The subject has a known allergy to iodine and has previously been refractory to pretreatment medications
  • The subject has been treated with tPA more than 4.5 hours after the last known well time
  • The subject is currently participating in another investigational drug or device study or registry
  • The subject has a serious, advanced, or terminal illness (as determined by the investigator) or a life expectancy of less than six months
  • The subject has a pre-existing medical, neurological, or psychiatric disease that would interfere with neurological or functional evaluations, or is already participating in another drug or device study
  • The subject has symptoms consistent with stroke in multiple locations
  • The subject has seizures at stroke onset, which makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment
  • The subject has severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg) that is not treatable with medications
  • The subject has a known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or has recently undergone oral anticoagulant therapy with an INR greater than 3
  • The subject has a baseline blood glucose level of less than 50mg/dL (2.78 mmol) or greater than 400mg/dL (22.20 mmol)
  • The subject has a baseline platelet count of less than 50,000/uL
  • The subject is pregnant
  • The subject has contraindications for both MRI and CT contrast that prevent an MRI or CT contrast perfusion study. The hospital's local standard criteria should be applied to determine if contraindications exist
  • The subject is presumed to have a septic embolus, suspicion of bacterial endocarditis, or cerebral vasculitis
  • The subject has had clot retrieval attempted using a neurothrombectomy device within 24 hours of symptom onset

Where in China

  • Tianjin Huanhu HospitalTianjin, ChinaContact: Ming Wei, MD, PhDTaking people

About the trial

What the trial wants to find out

The goal of this clinical trial is to investigate if endovascular treatment (EVT) can effectively treat patients with large vessel occlusion (LVO) who present beyond the typical 24-hour window after symptom onset. The main questions it aims to answer are:

Read full original descriptionShow less

* Can EVT improve functional independence at 90 days for patients treated after 24 hours? * What is the safety profile of EVT in this delayed treatment group compared to best medical management (BMM)? Researchers will compare EVT outcomes in patients presenting after 24 hours to those receiving BMM to see if EVT offers significant benefits.

Participants will:

* Receive either EVT or BMM based on their eligibility. * Undergo CT angiography to assess collateral circulation and to confirm the presence of LVO. * Be followed for 90 days to evaluate functional outcomes and safety measures.

The 2 groups in the trial

  • Endovascular thrombectomyTreatment being tested
  • Best Medical ManagementNo study treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography: A Multicentre, Open-label, Registry-linked, Randomised Controlled Trial
Plain-language title
Tests clot removal in stroke patients treated more than a day after symptomsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 October 2024