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Completed

NCT Number: NCT06236828

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechanical Thrombectomy

Device

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

Primary outcomes

  1. 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

  1. Mortality

    Time frame: 90 days after EVT or SMT

    Death defined as a mRS score of 6

  2. Rate of mRS score of 0-2

    Time frame: 90 days after EVT or SMT

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

  3. Improvement of mRS score

    Time frame: 90 days after EVT or SMT

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

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

  4. Change of the National Institutes of Health Stroke Scale (NIHSS) score comparing to baseline

    Time frame: 24 hours and 5-7 days (or at discharge) after EVT

    The NIHSS score range from 0 (no deficit) to 42 (maximum deficit).

  5. Rate of successful revascularization (mTICI 2b-3) in target blood vessels of EVT group

    Time frame: Immediately after the completion of endovascular therapy.

  6. Rate of Intracranial hemorrhage (ICH)

    Time frame: Within 72 hours after EVT or SMT

  7. Rate of symptomatic intracranial hemorrhage (sICH)

    Time frame: Within 72 hours after EVT or SMT

    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.

  8. Rate of non-hemorrhage severe adverse event

    Time frame: Within 72 hours after EVT or SMT

    ulmonary infection, respiratory failure, heart failure, myocardial infarction, urinary infection, etc.

  9. Surgical instrument-related Complications

    Time frame: Within 72 hours after EVT or SMT

    Vascular perforation, arterial dissection, arterial embolism, or distal embolism, etc.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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