Acute Ischemic StrokeANGEL-BAONCT06101667
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
A study testing Best medical management and Endovascular treatment in people with Acute Ischemic Stroke and Basilar Artery Occlusion, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Basilar Artery Occlusion
- What is being tested?
- Best medical management and Endovascular treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2023to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years
- Acute basilar artery occlusion confirmed by CTA, MRA, or DSA
- Pre-stroke mRS of 0-2
- NIHSS score ≥ 10 before randomization
- Time interval from symptom onset (or last known well) to randomization within 24-72 hours
- Diffusion-weighted imaging(DWI)-based pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI) ≤3
- Time from completion of DWI imaging to randomization is ≤3 hours
- Each patient or their legal representative must provide written informed consent before enrolment
Who cannot join
- Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
- Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
- CT or MRI evidence of intracranial tumor (except small meningioma and cerebral aneurysm < 3mm in diameter)
- Known or highly suspected chronic occlusion of basilar artery
- History of contraindication for contrast medium (except mild rash)
- Current pregnant or breast-feeding
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- Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
- Life expectancy is less than 3 months
- Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months.
- Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
Trial locations and contacts
1 site in 1 country.
About this study
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）
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke, Basilar Artery Occlusion
- Being tested
- Best medical management, Endovascular treatment
- Keywords
- Acute Ischemic Stroke, Basilar Artery Occlusion, Extended Time Window, Endovascular Treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best medical managementDrug
Best medical management included assessment of vital signs and neurological deficits,airway protection respiratory support,circulation;blood pressure monitoring;nutritional support;complication control;symptomatic treatment;laboratory and imaging examinations;etiological analysis and evaluation; anti platelet（e.g. aspirin,adenosine diphosphate (ADP) receptor inhibitors,Adenosine reuptake inhibitors,Glycoprotein platelet inhibitors）；anticoagulation(e.g. warfarin, rivaroxaban,dabigatran,apixaban,edoxaban)；lipid lowering(e.g. Statins,Fibrates）；control of blood pressure(e.g. Thiazide diuretics,Potassium-sparing,Loop diuretic,Beta-blockers,Angiotensin II receptor blockers,Calcium channel blockers,Alpha blockers,Central alpha-2 receptor agonists);control of blood glucose(e.g. SULFONYLUREAS (SFUs),GLINIDES,BIGUANIDES,ALPHA-GLUCOSIDASE INHIBITORS: STARCH BLOCKERS,THIAZOLIDINEDIONES,GLP-1 ANALOGS,DPP-4 INHIBITORS,SGLT2 inhibitors); control of other risk factors
Endovascular treatmentProcedure or surgery
The strategies that were used for endovascular treatment included :stent retrievers (e.g., Solitaire® [Medtronic, USA], Trevo® [Stryker, USA], EMBOTRAP® [Johnson \& Johnson, USA], Captor® [HeartCare, China] and other stent-retriever systems) thromboaspiration (e.g., Penumbra® [Penumbra, USA], Afentta® [HeMo, China] and other aspiration systems)) balloon angioplasty (e.g., Gateway® [Stryker, USA], Neuro RX® [SinoMed, China], FocuStar® [HeMo, China] and other intracranial balloon catheter systems) stent deployment (e.g., Wingspan® [Stryker, USA], Apollo® [MircoPort, China], Enterprise® [Johnson \& Johnson, USA], Neuroform EZ® [Stryker, USA] and other Intracranial stent systems)) intraarterial thrombolysis (with alteplase or urokinase) combinations of above approaches that were left to the discretion of the treating team
| Study group | Role | What they receive |
|---|---|---|
| Best medical management | Active comparator | Patients randomly assigned to the control group should receive the best medical management according to the guidelines. Receives: Drug: Best medical management |
| Endovascular treatment | Experimental | 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. Receives: Procedure: Endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of modified Rankin scale 0-3 at 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.
Measured: 90±14 days after randomization
Secondary outcomes (6)
MRS score as an ordinal scale at 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.
Measured: 90±14 days after randomization
Rate of mRS 0-2 at 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.
Measured: 90±14 days after randomization
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization
The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Measured: 24 hours after randomization
NIHSS score at 7 days after randomization or discharge (whichever came first)
The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Measured: 7 days after randomization or at discharge
Functional health status and quality of life (EuroQol Five Dimensions) at 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.
Measured: 90±14 days after randomization
Proportion of basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA or MRA)
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, 1=incomplete or partial recanalization of the primary occlusion with no distal flow, 2=incomplete or partial recanalization of the primary occlusion with distal flow, or 3=complete recanalization of the primary occlusion with distal flow.
Measured: 18-36 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start16 Nov 2023
- Primary completion17 Mar 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Beijing Tiantan Hospital
- Investigators
- Feng Gao, MD, Principal investigator, Beijing Tiantan Hospital, Capital Medical UniverityZhongrong Miao, PhD, Principal investigator, Beijing Tiantan Hospital, Capital Medical Univerity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101667
- Sponsor's protocol ID
- HX-A-2023021
- Acronym
- ANGEL-BAO
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao F, Tong X, Yang M, Sun H, Qu S, Ju Y, Zhao X, Wang Y, Miao Z; ANGEL-BAO Study Group. Endovascular recanalisation for acute basilar artery occlusion with extended time window of 24-72 hours (ANGEL-BAO): study protocol for a randomised controlled trial. Stroke Vasc Neurol. 2026 Jul 8:svn-2025-005000. doi: 10.1136/svn-2025-005000. Online ahead of print.
PubMed 42419771