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

NCT ID: NCT06924996

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-12-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Endovascular Thrombectomy (EVT)

Intervention Type: PROCEDURE

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

Best Medical Management (BMM)

BMM was tailored according to institutional guidelines and included intravenous thrombolysis (IVT), antiplatelet therapy, anticoagulation, or multimodal combinations.

No interventions assigned to this group

Interventions

Endovascular Thrombectomy (EVT)

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years old;

2. Acute ischemic stroke in the posterior circulation, the onset of stroke (or last well known) to the enrollment time within 24 hours;

3. CTA/MRA/DSA confirmed acute basilar artery occlusion;

4. Posterior circulation large infarct: NCCT or DWI showed pc-ASPECTS ≤ 5 points, or pontine midbrain index (PMI) ≥ 3 points;

5. NIHSS score ≥10 points after the onset of the stroke and before enrollment;

6. Able to live independently before the onset of the disease (mRS score ≤2 points);

7. The subject or legal representative is able to sign the informed consent form.

Exclusion Criteria

1. Intracranial hemorrhage (except microhemorrhage) on CT/MRI ;

2. CT/MRI revealed large infarction in the cerebellar hemisphere, with significant mass effect causing compression of the fourth ventricle or brainstem;

3. CT or MRI showed bilateral complete thalamic infarction;

4. Occlusion of anterior and posterior circulation arteries confirmed by CTA/MRA/DSA;

5. The presence of intracranial tumors (except for small meningiomas and cerebral aneurysms with a diameter of <3mm);

6. Patients with known or highly suspected chronic basilar artery occlusion.;

7. Known severe allergy to contrast agents (except for mild rash);

8. Refractory hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure >110 mmHg) that cannot be controlled by drug therapy;

9. Known pregnant or lactating females, or positive pregnancy test before enrollment;

10. Acute cerebral infarction within 48 hours after cardiovascular and cerebrovascular intervention or major surgery (patients more than 48 hours can be enrolled).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Feng Gao

OTHER

Sponsor Role: lead

Responsible Party

Feng Gao

Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

gao feng, professor

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

KY2023-106-02

Identifier Type: -

Identifier Source: org_study_id