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

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 Overview

• Status: Completed
• Conditions: Stroke; Ischemic Stroke; Acute Ischemic Stroke
• Intervention / Treatment: Device: Mechanical Thrombectomy

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

From January 2020 to September 2022, ABAO patients at Xuanwu Hospital Capital Medical University and 10 branch centers underwent EVT or SMT.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endovascular Thrombectomy; For patients who onset within 4.5 hours and meet the criteria for intravenous thrombolysis treatment, they could receive intravenous thrombolysis treatment beforehand and bridging to endovascular therapy.	Device: Mechanical Thrombectomy; The endovascular mechanical thrombectomy methods mainly include stent retriever thrombectomy, ADAPT thrombus aspiration technique, or their combination.
Standard Medical Therapy; For patients who onset within 4.5 hours and met the criteria for intravenous thrombolysis treatment, recombinant tissue plasminogen activator (rt-PA) or urokinase, and other intravenous thrombolysis therapies should be pre-administrated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of modified Rankin Scale (mRS) score of 0-3 at 90 days	The mRS score range from 0 (no disability) to 6 (death)	90 days after EVT or SMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death defined as a mRS score of 6	90 days after EVT or SMT
Rate of mRS score of 0-2	The mRS score range from 0 (no disability) to 6 (death)	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)	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).	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
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.	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.	Within 72 hours after EVT or SMT
Surgical instrument-related Complications	Vascular perforation, arterial dissection, arterial embolism, or distal embolism, etc.	Within 72 hours after EVT or SMT

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Large Vessel Occlusion; Endovascular Thrombectomy; Standard Medical Therapy; Acute Basilar Artery Occlusion
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: MR-EPICS

Drug and device information, study documents

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