Evaluating endovascular treatment for acute basilar artery occlusion

Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window -- A Multicenter, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial（ANGEL-BAO）

This study is testing if a special procedure to treat blocked blood vessels in the brain can help people who have had a stroke caused by a basilar artery occlusion feel better compared to just using standard medical care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 224 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06101667 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of endovascular treatment compared to medical management in patients experiencing acute basilar artery occlusion within an extended time window of 24-72 hours from symptom onset. It is a multicentered, prospective, randomized, open-label clinical trial that will enroll 224 patients who meet specific inclusion criteria. Participants will be randomly assigned to either receive endovascular treatment or best medical management after providing informed consent.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with acute basilar artery occlusion who present with a moderate to severe stroke as indicated by their NIHSS score.

Not a fit: Patients with signs of intracranial hemorrhage or significant pre-existing brain conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with acute basilar artery occlusion, potentially improving outcomes in a critical time frame.

How similar studies have performed: While there have been studies on endovascular treatment for acute ischemic stroke, this specific approach for basilar artery occlusion within an extended time window is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age≥18 years
2. Acute basilar artery occlusion confirmed by CTA, MRA, or DSA
3. Pre-stroke mRS of 0-2
4. NIHSS score ≥ 10 before randomization
5. Time interval from symptom onset (or last known well) to randomization within 24-72 hours
6. Diffusion-weighted imaging(DWI)-based pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI) ≤3
7. Time from completion of DWI imaging to randomization is ≤3 hours
8. Each patient or their legal representative must provide written informed consent before enrolment

Exclusion Criteria:

1. Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
2. Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
3. CT or MRI evidence of intracranial tumor (except small meningioma and cerebral aneurysm \< 3mm in diameter)
4. Known or highly suspected chronic occlusion of basilar artery
5. History of contraindication for contrast medium (except mild rash)
6. Current pregnant or breast-feeding
7. Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
8. Life expectancy is less than 3 months
9. Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months.
10. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Feng Gao, MD — Beijing Tiantan Hospital, Capital Medical Univerity
• Study coordinator: Xu Tong, MD

Conditions Acute Ischemic Stroke; Basilar Artery Occlusion; Extended Time Window; Endovascular Treatment