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

NCT ID: NCT06236828

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2023-11-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Mechanical Thrombectomy

Intervention Type: DEVICE

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.

No interventions assigned to this group

Interventions

Mechanical Thrombectomy

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

MR-EPICS

Identifier Type: -

Identifier Source: org_study_id