The MRI-based Evaluation of Safety and Efficacy of EVT and SMT: A Retrospective, Multicenter Study

Xuanwu Hospital, Beijing200 enrolled

Overview

Acute Basilar Artery Occlusion (ABAO), a condition with a high risk of mortality or disability (up to 80%). The safety and efficacy of endovascular thrombectomy (EVT) in ABAO remains uncertain due to inconsistent evidence from random controlled trials (RCTs). Recent studies have explored the use of MRI in ABAO, this study aims to assess the efficacy and safety of EVT and standard medical therapy (SMT) in the treatment of ABAO within 24 hours of onset. It also aims to explore the feasibility and prognostic value of MRI-based assessment of ABAO infarction using AI image analysis software.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Stroke Acute Ischemic Stroke Ischemic Stroke

Interventions

Mechanical ThrombectomyDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Preliminary diagnosis of posterior circulation ischemic stroke based on clinical symptoms or imaging examinations. 2. Confirmation through CTA/MRA/DSA that there is occlusion of the basilar artery or the V4 segment of the vertebral artery leading to functional occlusion of the basilar artery. 3. Age 18 years and older. 4. Symptom onset within 24 hours. 5. Having a baseline MRI evaluation, including at least DWI and T2 FLAIR sequences (baseline MRI for the EVT group before the operation; baseline MRI for the SMT group within the treatment window (within 4.5 hours of onset) for thrombolytic patients before or during the thrombolysis process should initiate as early as possible; baseline MRI for the SMT group for extended treatment window patients (between 4.5 hours to 12 hours of onset) should initiate as early as possible). Exclusion Criteria: 1. mRS score ≥ 3 before onset; 2. Significant neuroimaging changes such as cerebral hemorrhage, cerebellar mass lesion, acute hydrocephalus, etc., are present; 3. Lack of follow-up results within 90 days after operation; 4. Life expectancy \< 3 months; 5. Baseline imaging and crucial clinical data are missing; 6. Special cases involving pregnancy and lactation; 7. Severe systemic diseases or advanced cancer that may potentially interfere with the prognosis; 8. Allergic reactions to contrast agents or nickel-titanium alloys; 9. Currently participating in other clinical trials; 10. Pre-existing neurological disorders or psychiatric conditions that could affect the assessment of the disease.

Outcomes

Primary Outcomes

Rate of modified Rankin Scale (mRS) score of 0-3 at 90 days

The mRS score range from 0 (no disability) to 6 (death)

Time frame: 90 days after EVT or SMT

Secondary Outcomes

Mortality

Death defined as a mRS score of 6

Time frame: 90 days after EVT or SMT

Rate of mRS score of 0-2

The mRS score range from 0 (no disability) to 6 (death)

Time frame: 90 days after EVT or SMT

Improvement of mRS score

The mRS score range from 0 (no disability) to 6 (death) The mRS score range from 0 (no disability) to 6 (death)

Time frame: 90 days after EVT or SMT

Change of the National Institutes of Health Stroke Scale (NIHSS) score comparing to baseline

The NIHSS score range from 0 (no deficit) to 42 (maximum deficit).

Time frame: 24 hours and 5-7 days (or at discharge) after EVT

Rate of successful revascularization (mTICI 2b-3) in target blood vessels of EVT group

Time frame: Immediately after the completion of endovascular therapy.

Rate of Intracranial hemorrhage (ICH)

Time frame: Within 72 hours after EVT or SMT

Rate of symptomatic intracranial hemorrhage (sICH)

The sICH was assessed based on the Heidelberg Bleeding Classification, defined as 1) ≥4 points total NIHSS at the time of diagnosis compared to immediately before worsening; 2) ≥2 point in one NIHSS category. The rationale for this is to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; 3) Leading to intubation/hemicraniectomy/EVD placement or other major medical/surgical intervention; 4) Absence of alternative explanation for deterioration.

Time frame: Within 72 hours after EVT or SMT

Rate of non-hemorrhage severe adverse event

ulmonary infection, respiratory failure, heart failure, myocardial infarction, urinary infection, etc.

Time frame: Within 72 hours after EVT or SMT

Surgical instrument-related Complications

Vascular perforation, arterial dissection, arterial embolism, or distal embolism, etc.

Time frame: Within 72 hours after EVT or SMT

The MRI-based Evaluation of Safety and Efficacy of EVT and SMT: A Retrospective, Multicenter Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes