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

Xuanwu Hospital, Beijing1 site in 1 country200 target enrollmentJanuary 31, 2023

ConditionsStroke Acute Ischemic Stroke Ischemic Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Xuanwu Hospital, Beijing
Enrollment: 200
Locations: 1
Primary Endpoint: Rate of modified Rankin Scale (mRS) score of 0-3 at 90 days
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 31, 2023

End Date

November 1, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Xuanwu Hospital, Beijing

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Preliminary diagnosis of posterior circulation ischemic stroke based on clinical symptoms or imaging examinations.
•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.
•Age 18 years and older.
•Symptom onset within 24 hours.
•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

•mRS score ≥ 3 before onset;
•Significant neuroimaging changes such as cerebral hemorrhage, cerebellar mass lesion, acute hydrocephalus, etc., are present;
•Lack of follow-up results within 90 days after operation;
•Life expectancy \< 3 months;
•Baseline imaging and crucial clinical data are missing;
•Special cases involving pregnancy and lactation;
•Severe systemic diseases or advanced cancer that may potentially interfere with the prognosis;
•Allergic reactions to contrast agents or nickel-titanium alloys;
•Currently participating in other clinical trials;
•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

Time Frame: 90 days after EVT or SMT

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

Secondary Outcomes

Mortality(90 days after EVT or SMT)
Rate of mRS score of 0-2(90 days after EVT or SMT)
Rate of non-hemorrhage severe adverse event(Within 72 hours after EVT or SMT)
Improvement of mRS score(90 days after EVT or SMT)
Surgical instrument-related Complications(Within 72 hours after EVT or SMT)
Rate of symptomatic intracranial hemorrhage (sICH)(Within 72 hours after EVT or SMT)
Change of the National Institutes of Health Stroke Scale (NIHSS) score comparing to baseline(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(Immediately after the completion of endovascular therapy.)
Rate of Intracranial hemorrhage (ICH)(Within 72 hours after EVT or SMT)