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

NCT06236828 | Completed

• 1 other identifier: MR-EPICS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Acute Ischemic Stroke; Ischemic Stroke

Keywords

MRI; Endovascular Thrombectomy; Standard Medical Therapy; Large Vessel Occlusion; Acute Basilar Artery Occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Mortality

  90 days after EVT or SMT

• Rate of mRS score of 0-2

  90 days after EVT or SMT

• Improvement of mRS score

  90 days 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.

Study Arms (2)

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

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.

Interventions

Mechanical Thrombectomy DEVICE

The endovascular mechanical thrombectomy methods mainly include stent retriever thrombectomy, ADAPT thrombus aspiration technique, or their combination.

Endovascular Thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: February 1, 2024
• Study Start: January 31, 2023
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 1, 2024

Record last verified: 2023-01

Locations

CN (1)