Acute Basilar Artery OcclusionNCT06924996

Efficacy and Safety of Endovascular Thrombectomy in Acute Ischemic Stroke With Posterior Circulation Large Infarct

An observational study of Acute Basilar Artery Occlusion and Posterior Circulation Large Infarct, run by Feng Gao at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

The purpose of this study is to evaluate whether endovascular thrombectomy (EVT) combined with best medical management (BMM) leads to better functional outcomes than BMM alone in patients with acute basilar artery occlusion with posterior circulation large infarct. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Acute Basilar Artery Occlusion, Posterior Circulation Large Infarct
What is being tested?: Endovascular Thrombectomy (EVT)
Type of treatment: Injection or infusion, Surgery or procedure
How many people: 500 participants
Where: 1 siteChina
Study dates: 1 Jan 2023to 31 Dec 2025
How long will I take part?: 90 Days
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Acute basilar artery occlusion with large infarct

Who may be able to join

Age 18-80 years old;
Acute ischemic stroke in the posterior circulation, the onset of stroke (or last well known) to the enrollment time within 24 hours;
CTA/MRA/DSA confirmed acute basilar artery occlusion;
Posterior circulation large infarct: NCCT or DWI showed pc-ASPECTS ≤ 5 points, or pontine midbrain index (PMI) ≥ 3 points;
NIHSS score ≥10 points after the onset of the stroke and before enrollment;
Able to live independently before the onset of the disease (mRS score ≤2 points);
The subject or legal representative is able to sign the informed consent form.

Who cannot join

Intracranial hemorrhage (except microhemorrhage) on CT/MRI ;
CT/MRI revealed large infarction in the cerebellar hemisphere, with significant mass effect causing compression of the fourth ventricle or brainstem;
CT or MRI showed bilateral complete thalamic infarction;
Occlusion of anterior and posterior circulation arteries confirmed by CTA/MRA/DSA;
The presence of intracranial tumors (except for small meningiomas and cerebral aneurysms with a diameter of <3mm);
Patients with known or highly suspected chronic basilar artery occlusion.;

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Known severe allergy to contrast agents (except for mild rash);
Refractory hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure >110 mmHg) that cannot be controlled by drug therapy;
Known pregnant or lactating females, or positive pregnancy test before enrollment;
Acute cerebral infarction within 48 hours after cardiovascular and cerebrovascular intervention or major surgery (patients more than 48 hours can be enrolled).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: Efficacy and Safety of Endovascular Thrombectomy in Acute Ischemic Stroke With Posterior Circulation Large Infarct: A Multicenter, Prospective, Cohort Study

Read the detailed description

This study is a multicenter, prospective, cohort study that prospectively enrolled consecutive patients with acute basilar artery occlusion and large core infarction in the posterior circulation, confirmed by imaging (CTA/MRA/DSA). Written informed consent was obtained from all participants or their legal representatives prior to enrollment. Patients were divided into the best medical management (BMM) group and the endovascular thrombectomy (EVT) group according to the treatment they received. This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

Conditions: Acute Basilar Artery Occlusion, Posterior Circulation Large Infarct
Being tested: Endovascular Thrombectomy (EVT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endovascular Thrombectomy (EVT)Procedure or surgery
A maximum of six attempts to retrieve the thrombus in a single vessel can be made with any Solitaire AB/FR device or aspiration. In case an atherosclerotic lesion is found underlying the occlusive lesion, angioplasty and subsequent stenting through detachment of the Solitaire device will be allowed

Study groups in NCT06924996
Study group	Role	What they receive
Endovascular Thrombectomy (EVT)		The EVT group would include the following interventions: stent-retriever thrombectomy, aspiration thrombectomy, balloon angioplasty and/or stenting, intra-arterial medication administration, or a combination of these approaches. Receives: Procedure: Endovascular Thrombectomy (EVT)
Best Medical Management (BMM)		BMM was tailored according to institutional guidelines and included intravenous thrombolysis (IVT), antiplatelet therapy, anticoagulation, or multimodal combinations.

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of modified Rankin scale 0-3 at 90 (±14) days after enrollment
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.
Measured: 90 (±14) days

Secondary outcomes (3)

Ordinal Shift analysis of mRS score at 90 (±14) days after enrollment
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.
Measured: 90 (±14) days
Rate of mRS 0-2 at 90 (±14) days after enrollment
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.
Measured: 90 (±14) days
Rate of Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after enrollment
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
Measured: 90 (±14) days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202331 Dec 2025

First posted13 Apr 2025
Study start1 Jan 2023
Primary completion31 Aug 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Basilar Artery OcclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 500 participants (estimated)
Target duration: 90 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT06924996
Sponsor's protocol ID: KY2023-106-02
Status last verified: Apr 2025
First submitted: 10 Apr 2025
Last updated: 13 Apr 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
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Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core
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Rescue Endovascular Treatment After Neurological Deterioration in Initially Mild Basilar Artery Occlusion in an Extended Time Window
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Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours
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Not yet recruiting
The Efficacy and Safety of Endovascular Treatment for Acute Mild Basilar Artery Occlusion
Acute Mild Basilar Artery Occlusion, Basilar Artery Occlusion

All Acute Basilar Artery Occlusion trials