Comparing two treatments for acute basilar artery occlusion

Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Endovascular Thrombectomy on Acute Basilar Artery Occlusion - a Multicenter, Randomized Controlled, Clinical Trial

This study is testing whether a procedure to remove a blood clot from the basilar artery by itself works as well as a combination of that procedure with a different medication for people who have a blockage in that artery.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 338 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of University of Science and Technology of China (other)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT05827042 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of endovascular thrombectomy alone versus intravenous thrombolysis combined with thrombectomy in patients suffering from acute basilar artery occlusion. Participants will be randomized within 4.5 hours of symptom onset to receive one of the two treatment approaches. The study seeks to determine if thrombectomy alone can achieve similar functional independence outcomes at 90 days compared to the combination therapy. This research builds on previous trials that have shown promising results for thrombectomy in similar conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older presenting with acute ischemic stroke symptoms due to basilar artery occlusion within 4.5 hours of onset.

Not a fit: Patients with evidence of intracerebral hemorrhage or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with acute basilar artery occlusion, potentially improving recovery outcomes.

How similar studies have performed: Previous studies have shown success with similar approaches in treating large vessel occlusions, indicating potential for this study's methodology.

Eligibility criteria

Inclusion Criteria:

1. Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery;
2. Time from stroke onset to randomization within 4.5 hours of estimated time of basilar artery occlusion;
3. Patient's age ≥ 18 years;
4. Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In case of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery;
5. Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard criteria;
6. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 10;
7. The patient or patient's legal representative signs the informed consent form.

Exclusion Criteria:

1. CT or MR evidence of intracerebral hemorrhage (the presence of \< 10 microbleeds is allowed);
2. Pre-stroke modified Rankin scale (mRS) score ≥ 2;
3. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images\<6; PC-ASPECTS on magnetic resonance imaging-diffusion weighted imaging (MRI-DWI) \<5;
4. Pregnant or lactating women;
5. Allergy to contrast agent or nitinol alloy;
6. Life expectancy\<1 year;
7. CTA/MRA/DSA show vascular tortuosity, anatomical variation or artery dissection, which would make it difficult to perform endovascular treatment;
8. Participating in other clinical trials;
9. Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, which can not be controlled by antihypertensive drugs;
10. Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; oral anticoagulant with international normalized ratio (INR) \> 1.7; or novel oral anticoagulant within prior 48 hours;
11. Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L), platelet\< 100\*109/L;
12. Renal insufficiency defined as serum creatinine \>2.0 mg/dl (or 176.8 μ mol/l), glomerular filtration rate \<30 mL/min, need for hemodialysis or peritoneal dialysis;
13. Patients who cannot complete 90-day follow-up (such as patients without fixed residence, overseas patients, etc);
14. The patient has acute ischemic cerebral infarction within 3 months from randomization;
15. The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis;
16. The patient has nervous system disease or mental disorder before stroke onset, which may affect the assessment of their condition;
17. CT or MR examination showed large cerebellar infarction with obvious space occupying effect and compression of the fourth ventricle;
18. Patients with extensive bilateral thalamic or extensive bilateral brainstem infarction on CT or MR examination;
19. CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion;
20. Patients with intracranial tumors (except small meningiomas);
21. Patients who received intravenous thrombolytics treatment before the randomization.

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Wei Hu, MD

Conditions: Basilar Artery Occlusion, Acute Cerebrovascular Accident, Stroke Due to Basilar Artery Occlusion, Thrombectomy, thrombolysis