Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Best medical management Patients randomly assigned to the control group should receive the best medical management according to the guidelines. |
Drug: Best medical management
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
|
| Experimental: Endovascular treatment 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. |
Procedure: Endovascular treatment
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
|
Outcome Measures
Primary Outcome Measures
- Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization [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 Outcome Measures
- Rate of mRS score as an ordinal scale at 90 (±14) days after randomization [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.
- Rate of mRS 0-2 at 90 (±14) days after randomization [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.
- Rate of National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization [24 hours after randomization]
The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
- Rate of NIHSS score at 7 (±3) days after randomization or discharge (whichever came first) [7 (±3) 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.
- Rate of Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization [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.
- Proportion of basilar artery recanalization at 18-36 hours after randomization [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, I=incomplete or partial recanalization of the primary occlusion with no distal flow, II=incomplete or partial recanalization of the primary occlusion with distal flow, or III=complete recanalization of the primary occlusion with distal flow.
Other Outcome Measures
- Rate of any Symptomatic intracranial hemorrhage (SICH) defined as the Heidelberg classification within 18-36 hours of randomization [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.
- 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 (±3) days after randomization [7 (±3) days after randomization]
All cause of mortality within 7 (±3) days after randomization
- All cause of mortality within 90 (±14) days after randomization [90±14 days after randomization]
All cause of mortality within 90 (±14) days after randomization
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age≥18 years
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Pre-stroke mRS of 0-2
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NIHSS score ≥ 10 before randomization
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Time interval from symptom onset (or last known well) to randomization within 24-72 hours
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Diffusion-weighted imaging(DWI)-based pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI) < 3
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Each patient or their legal representative must provide written informed consent before enrolment
Exclusion Criteria:
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Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
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Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
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CT or MRI evidence of intracranial tumor (except small meningioma and cerebral aneurysm < 3mm in diameter)
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Known or highly suspected chronic occlusion of basilar artery
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History of contraindication for contrast medium (except mild rash)
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Current pregnant or breast-feeding
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Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
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Life expectancy is less than 3 months
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Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months.
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Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Tiantan Hospital | Beijing | Beijing | China | 100070 |
Sponsors and Collaborators
- Beijing Tiantan Hospital
Investigators
- Principal Investigator: Feng Gao, MD, Beijing Tiantan Hospital, Capital Medical Univerity
- Principal Investigator: Zhongrong Miao, PhD, Beijing Tiantan Hospital, Capital Medical Univerity
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HX-A-2023021