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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06236828
• Other study ID #: MR-EPICS
• Status: Completed
• Start date: January 31, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Mechanical Thrombectomy
The endovascular mechanical thrombectomy methods mainly include stent retriever thrombectomy, ADAPT thrombus aspiration technique, or their combination.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Death defined as a mRS score of 6	90 days after EVT or SMT
Secondary	Rate of mRS score of 0-2	The mRS score range from 0 (no disability) to 6 (death)	90 days after EVT or SMT
Secondary	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
Secondary	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
Secondary	Rate of successful revascularization (mTICI 2b-3) in target blood vessels of EVT group		Immediately after the completion of endovascular therapy.
Secondary	Rate of Intracranial hemorrhage (ICH)		Within 72 hours after EVT or SMT
Secondary	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
Secondary	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
Secondary	Surgical instrument-related Complications	Vascular perforation, arterial dissection, arterial embolism, or distal embolism, etc.	Within 72 hours after EVT or SMT