Comparing thrombectomy and medical management for stroke patients treated after 24 hours

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

This study is testing if a special procedure to remove blood clots can help stroke patients who arrive more than 24 hours after their symptoms start, compared to just using medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Huanhu Hospital (Academic / other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06654375 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of endovascular treatment (EVT) for patients with large vessel occlusion (LVO) who present more than 24 hours after stroke onset. It aims to determine if EVT can improve functional independence at 90 days compared to best medical management (BMM) in this delayed treatment group. Participants will undergo CT angiography to confirm LVO and assess collateral circulation before being randomized to receive either EVT or BMM. The study will follow participants for 90 days to evaluate their functional outcomes and safety profiles.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed LVO and moderate to good collateral flow who present between 24 to 72 hours after stroke onset.

Not a fit: Patients with significant pre-stroke disability or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for stroke patients who present beyond the typical treatment window.

How similar studies have performed: While studies on EVT for acute ischemic stroke have shown promise, this specific approach for patients presenting after 24 hours is relatively novel and untested.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Demonstration of moderate to good collateral flow, as evidenced by CTA imaging.
3. The patient must be aged 18 years or older.
4. 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.
5. 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).
6. There must be no significant pre-stroke disability, as indicated by a pre-baseline modified Rankin Scale score of 0-2.
7. The patient must be willing and able to return for the protocol-required follow-up visits.
8. The patient or their legally authorized representative must have signed the Informed Consent form.

Exclusion Criteria:

1. The subject has a serious, advanced, or terminal illness (as determined by the investigator) or a life expectancy of less than six months.
2. 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.
3. The subject is pregnant.
4. 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.
5. The subject has a known allergy to iodine and has previously been refractory to pretreatment medications.
6. The subject has been treated with tPA more than 4.5 hours after the last known well time.
7. 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.
8. The subject has symptoms consistent with stroke in multiple locations.
9. The subject has seizures at stroke onset, which makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
10. The subject has a baseline blood glucose level of less than 50mg/dL (2.78 mmol) or greater than 400mg/dL (22.20 mmol).
11. The subject has a baseline platelet count of less than 50,000/uL.
12. The subject has severe, sustained hypertension (Systolic Blood Pressure \>185 mmHg or Diastolic Blood Pressure \>110 mmHg) that is not treatable with medications.
13. The subject is currently participating in another investigational drug or device study or registry.
14. The subject is presumed to have a septic embolus, suspicion of bacterial endocarditis, or cerebral vasculitis.
15. The subject has had clot retrieval attempted using a neurothrombectomy device within 24 hours of symptom onset.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Huanhu Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ming Wei, MD, PhD

Conditions Stroke Acute; Thrombectomy; Medical Treatment; Large Vessel Occlusion; CTA; Endovascular Thrombectomy; Acute Ischemic Stroke