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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best medical management | Active Comparator | Patients randomly assigned to the control group should receive the best medical management according to the guidelines. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best medical management | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90±14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90±14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of any Symptomatic intracranial hemorrhage (SICH) defined as the Heidelberg classification within 18-36 hours of randomization | Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening. 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Tong, MD | Contact | +8617611338800 | dongri0514@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Gao, MD | Beijing Tiantan Hospital, Capital Medical Univerity | Principal Investigator |
| Zhongrong Miao, PhD | Beijing Tiantan Hospital, Capital Medical Univerity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42419771 | Derived | 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. |
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| Endovascular treatment | Procedure | 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 |
|
| 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. | 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. | 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. | 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. | 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. | 18-36 hours after randomization |
| 18-36 hours after randomization |
| Rate of any Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours after randomization | Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours | Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours |
| All cause of mortality within 7 days after randomization | All cause of mortality within 7 days after randomization | 7 days after randomization |
| All cause of mortality within 90 (±14) days after randomization | All cause of mortality within 90 (±14) days after randomization | 90±14 days after randomization |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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