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

NCT06924996 | Enrolling By Invitation

• 1 other identifier: KY2023-106-02
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Basilar Artery Occlusion; Posterior Circulation Large Infarct

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Ordinal Shift analysis of mRS score at 90 (±14) days after enrollment

  90 (±14) days

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

  90 (±14) days

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

  90 (±14) days

Other Outcomes (2)

• Mortality within 90 (±14) days

  90 (±14) days

• Rate of Symptomatic intracranial hemorrhage (SICH)

  24-72 hours

Study Arms (2)

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)

Best Medical Management (BMM)

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

Interventions

Endovascular Thrombectomy (EVT) 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

Endovascular Thrombectomy (EVT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute basilar artery occlusion with large infarct

You may qualify if:

• 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.

You may not qualify if:

• 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.;
• 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).

Sponsors & Collaborators

• Feng Gao: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Study Officials

• gao feng, professor

  Beijing Tiantan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 13, 2025
• Study Start: January 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

CN (1)