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

NCT06101667 | Recruiting DMC

• 1 other identifier: HX-A-2023021
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke; Basilar Artery Occlusion

Keywords

Acute Ischemic Stroke; Basilar Artery Occlusion; Extended Time Window; Endovascular Treatment

Outcome Measures

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.

  90±14 days after randomization

Secondary Outcomes (6)

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

  90±14 days after randomization

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

  90±14 days after randomization

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

  24 hours after randomization

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

  7 days after randomization or at discharge

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

  90±14 days after randomization

Other Outcomes (4)

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

• All cause of mortality within 7 days after randomization

  7 days after randomization

Study Arms (2)

Best medical management

ACTIVE COMPARATOR

Patients randomly assigned to the control group should receive the best medical management according to the guidelines.

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.

Procedure: Endovascular treatment

Interventions

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

Best medical management

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

Endovascular treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Feng Gao, MD

  Beijing Tiantan Hospital, Capital Medical Univerity

  PRINCIPAL INVESTIGATOR

• Zhongrong Miao, PhD

  Beijing Tiantan Hospital, Capital Medical Univerity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Tong, MD

CONTACT

+8617611338800; dongri0514@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Director of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 26, 2023
• Study Start: November 16, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)