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

Not Applicable

Recruiting

• Conditions: Basilar Artery Occlusion; Acute Ischemic Stroke
• Interventions: Drug: Best medical management; Procedure: Endovascular treatment

• Registration Number: NCT06101667
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-10-15
• Study First Submitted: 2023-10-15
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. Age≥18 years
2. Pre-stroke mRS of 0-2
3. NIHSS score ≥ 10 before randomization
4. Time interval from symptom onset (or last known well) to randomization within 24-72 hours
5. Diffusion-weighted imaging(DWI)-based pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI) ≤3
6. Time from completion of DWI imaging to randomization is ≤3 hours
7. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best medical management	Best medical management	Patients randomly assigned to the control group should receive the best medical management according to the guidelines.
Endovascular treatment	Endovascular treatment	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.

Primary Outcome Measures

Name	Time	Method
Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization	90±14 days after randomization	The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.

Secondary Outcome Measures

Name	Time	Method
Rate of Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization	90±14 days after randomization	EuroQol Five Dimensions (EQ-5D) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Proportion of basilar artery recanalization at 18-36 hours after randomization	18-36 hours after randomization	Basilar artery recanalization is defined as grade 2-3 of arterial occlusive lesion (AOL) scale.; The AOL Score was defined as: 0=no recanalization of the primary occlusion, I=incomplete or partial recanalization of the primary occlusion with no distal flow, II=incomplete or partial recanalization of the primary occlusion with distal flow, or III=complete recanalization of the primary occlusion with distal flow.
Rate of mRS 0-2 at 90 (±14) days after randomization	90±14 days after randomization	The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Rate of mRS score as an ordinal scale at 90 (±14) days after randomization	90±14 days after randomization	The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Rate of National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization	24 hours after randomization	The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Rate of NIHSS score at 7 (±3) days after randomization or discharge (whichever came first)	7 (±3) days after randomization or at discharge	The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China