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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18 years

Acute basilar artery occlusion confirmed by CTA, MRA, or DSA

Pre-stroke mRS of 0-2

NIHSS score ≥ 10 before randomization

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/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

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: Best medical managementActive comparator 1 intervention
Group B: Endovascular treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
90±14 days after randomization

Secondary outcomes

1

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.

Time frame
90±14 days after randomization
2

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.

Time frame
90±14 days after randomization
3

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.

Time frame
24 hours after randomization
4

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.

Time frame
7 days after randomization or at discharge

Other outcomes

1

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.

Time frame
18-36 hours after randomization
2

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

Time frame
Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours
3

All cause of mortality within 7 days after randomization

All cause of mortality within 7 days after randomization

Time frame
7 days after randomization
4

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

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

Time frame
90±14 days after randomization

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