Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)

Capital Medical University

Status: Enrolling

Conditions: Basilar Artery Occlusion; Acute Ischemic Stroke

Treatments: Procedure: Endovascular treatment; Drug: Best medical management

Study type: Interventional

Funder types: Other

Identifiers

NCT06101667

HX-A-2023021

Details and patient eligibility

About

The aim of this study is to assess the efficacy and safety of endovascular treatment versus medical management in patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset.

Full description

The ANGEL-BAO is a multicentered, prospective, randomized, open-label, blinded end-point clinical trial. A total of 224 patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (endovascular treatment or medical management) after offering informed content.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

Best medical management

Active Comparator group

Description:

Patients randomly assigned to the control group should receive the best medical management according to the guidelines.

Treatment:

Drug: Best medical management

Endovascular treatment

Experimental group

Description:

Stent retrievers, thromboaspiration, balloon angioplasty, stent deployment, intra-arterial thrombolysis (Recombinant tissue plasminogen activator (rt-PA) or urokinase), or the various combinations of these approaches.

Treatment:

Procedure: Endovascular treatment