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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acute Basilar Artery Occlusion; Posterior Circulation Large Infarct
• Intervention / Treatment: Procedure: Endovascular Thrombectomy (EVT)

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Acute basilar artery occlusion with large infarct

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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
Best Medical Management (BMM); BMM was tailored according to institutional guidelines and included intravenous thrombolysis (IVT), antiplatelet therapy, anticoagulation, or multimodal combinations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 (±14) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	90 (±14) days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality within 90 (±14) days	all-cause mortality	90 (±14) days
Rate of Symptomatic intracranial hemorrhage (SICH)	Symptomatic intracranial hemorrhage (SICH) within 24-72 hours after enrollment	24-72 hours

Collaborators and Investigators

• Sponsor: Feng Gao
• Investigators: Study Chair: gao feng, professor, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Necrosis; Ischemia; Stroke; Ischemic Stroke; Infarction
• Other Study ID Numbers: KY2023-106-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No