Clinical trial NCT06236828: The MRI-based Evaluation of Safety and Efficacy of EVT and SMT: A Retrospective, Multicenter Study
Official title: The MRI-based Evaluation of Safety and Efficacy of EVT and SMT: A Retrospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Acute Ischemic Stroke
Ischemic Stroke
Keywords: MRI
Endovascular Thrombectomy
Standard Medical Therapy
Large Vessel Occlusion
Acute Basilar Artery Occlusion
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Rate of modified Rankin Scale (mRS) score of 0-3 at 90 days
timeFrame: 90 days after EVT or SMT
Secondary outcomes:
measure: Mortality
timeFrame: 90 days after EVT or SMT
measure: Rate of mRS score of 0-2
timeFrame: 90 days after EVT or SMT
measure: Improvement of mRS score
timeFrame: 90 days after EVT or SMT
measure: Change of the National Institutes of Health Stroke Scale (NIHSS) score comparing to baseline
timeFrame: 24 hours and 5-7 days (or at discharge) after EVT
measure: Rate of successful revascularization (mTICI 2b-3) in target blood vessels of EVT group
timeFrame: Immediately after the completion of endovascular therapy.
measure: Rate of Intracranial hemorrhage (ICH)
timeFrame: Within 72 hours after EVT or SMT
measure: Rate of symptomatic intracranial hemorrhage (sICH)
timeFrame: Within 72 hours after EVT or SMT
measure: Rate of non-hemorrhage severe adverse event
timeFrame: Within 72 hours after EVT or SMT
measure: Surgical instrument-related Complications
timeFrame: Within 72 hours after EVT or SMT
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References: