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Completed

NCT Number: NCT06101667

Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (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.

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Key information

Conditions

Acute Ischemic Stroke Basilar Artery Occlusion Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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

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

Primary outcomes

  1. Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization

    Time frame: 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 outcomes

  1. MRS score as an ordinal scale at 90 (±14) days after randomization

    Time frame: 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.

  2. Rate of mRS 0-2 at 90 (±14) days after randomization

    Time frame: 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.

  3. National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization

    Time frame: 24 hours after randomization

    The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.

  4. NIHSS score at 7 days after randomization or discharge (whichever came first)

    Time frame: 7 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.

  5. Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization

    Time frame: 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.

  6. Proportion of basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA or MRA)

    Time frame: 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, 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.

Other outcomes

  1. Rate of any Symptomatic intracranial hemorrhage (SICH) defined as the Heidelberg classification within 18-36 hours of randomization

    Time frame: 18-36 hours after 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.

  2. Rate of any Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours after randomization

    Time frame: 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

  3. All cause of mortality within 7 days after randomization

    Time frame: 7 days after randomization

    All cause of mortality within 7 days after randomization

  4. All cause of mortality within 90 (±14) days after randomization

    Time frame: 90±14 days after randomization

    All cause of mortality within 90 (±14) days after randomization

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study 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）

Acronym: ANGEL-BAO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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