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

Acute Ischemic Stroke Clinical Trial

— ANGEL-BAO  

Official 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）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101667
• Other study ID #: HX-A-2023021
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Beijing Tiantan Hospital
• Contact: Xu Tong, MD
• Phone: +8617611338800
• Email: dongri0514[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age=18 years

2. Pre-stroke mRS of 0-2

3. NIHSS score = 10 before randomization

4. Time interval from symptom onset (or last known well) to randomization within 24-72 hours

5. Diffusion-weighted imaging(DWI)-based pc-ASPECTS = 6 and Pons-Midbrain Index (PMI) =3

6. Time from completion of DWI imaging to randomization is =3 hours

7. Each patient or their legal representative must provide written informed consent before enrolment

Exclusion Criteria:

1. Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization

2. Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging

3. CT or MRI evidence of intracranial tumor (except small meningioma and cerebral aneurysm < 3mm in diameter)

4. Known or highly suspected chronic occlusion of basilar artery

5. History of contraindication for contrast medium (except mild rash)

6. Current pregnant or breast-feeding

7. Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up

8. Life expectancy is less than 3 months

9. Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months.

10. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Arterial Occlusive Diseases
• Basilar Artery Occlusion
• Ischemic Stroke

Intervention

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

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	18-36 hours after randomization
Other	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
Other	All cause of mortality within 7 (±3) days after randomization	All cause of mortality within 7 (±3) days after randomization	7 (±3) days after randomization
Other	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
Primary	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	Rate of 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
Secondary	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
Secondary	Rate of 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
Secondary	Rate of NIHSS score at 7 (±3) 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 (±3) days after randomization or at discharge
Secondary	Rate of 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
Secondary	Proportion of basilar artery recanalization at 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.	18-36 hours after randomization