Clinical trial NCT06101667: Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Official title: 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）
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Basilar Artery Occlusion
Keywords: Acute Ischemic Stroke
Basilar Artery Occlusion
Extended Time Window
Endovascular Treatment
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization
timeFrame: 90±14 days after randomization
Secondary outcomes:
measure: MRS score as an ordinal scale at 90 (±14) days after randomization
timeFrame: 90±14 days after randomization
measure: Rate of mRS 0-2 at 90 (±14) days after randomization
timeFrame: 90±14 days after randomization
measure: National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization
timeFrame: 24 hours after randomization
measure: NIHSS score at 7 days after randomization or discharge (whichever came first)
timeFrame: 7 days after randomization or at discharge
measure: Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization
timeFrame: 90±14 days after randomization
measure: Proportion of basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA or MRA)
timeFrame: 18-36 hours after randomization
Other outcomes:
measure: Rate of any Symptomatic intracranial hemorrhage (SICH) defined as the Heidelberg classification within 18-36 hours of randomization
timeFrame: 18-36 hours after randomization
measure: Rate of any Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours after randomization
timeFrame: Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours
measure: All cause of mortality within 7 days after randomization
timeFrame: 7 days after randomization
measure: All cause of mortality within 90 (±14) days after randomization
timeFrame: 90±14 days after randomization
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital, Capital Medical Univerity
name: Feng Gao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital, Capital Medical Univerity
name: Zhongrong Miao, PhD
role: PRINCIPAL_INVESTIGATOR
References: