Safety and Efficacy of Endovascular Treatment for Acute Basilar Artery Occlusion in the Extended Time Window -a Prospective, Multicenter, Randomized Controlled, Open-label Clinical Trial

Capital Medical University1 site in 1 country309 target enrollmentAugust 16, 2024

ConditionsAcute Ischemic Stroke Basilar Artery Occlusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: Capital Medical University
Enrollment: 309
Locations: 1
Primary Endpoint: Difference in proportion of patients achieving favorable outcomes (defined as mRS 0-3) at 90 days
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial to evaluate the safety and efficacy of endovascular mechanical thrombectomy for acute basilar artery occlusion in the extended time window

Detailed Description

This trial aims to evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving favorable outcomes in subjects presenting with stroke due to basilar artery occlusion in the extended time window of 24-72 hours from symptom onset or time last seen well. In this trial, the randomization will employ a 2:1 ratio of mechanical thrombectomy versus best medical management alone. Randomization will be stratified according to age (18-70 or \>70), baseline NIHSS (6-20 or \>20) and therapeutic window (24-48 hours or \>48 hours). For the primary endpoint, subjects will be followed for 90 days post-randomization.

Registry

clinicaltrials.gov

Start Date

August 16, 2024

End Date

June 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Capital Medical University

Responsible Party

Principal Investigator

Ji Xunming,MD,PhD

Professor

Capital Medical University

Eligibility Criteria

Inclusion Criteria

•Posterior circulation acute ischemic stroke within 24-72 hours from symptom onset/last seen well (except for isolated vertigo), where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., patient presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without recanalization.
•Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
•Age ≥18 and ≤
•Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points.
•No significant pre-stroke functional disability (mRS ≤ 1).
•Patient treatable within 72 hours of symptom onset. Symptom onset is defined as the point in time the patient was last seen well (at baseline) if patients are unable to provide a reliable history or the point in time when symptoms have started if patients can provide a reliable history.
•Informed consent obtained from patient or authorized patient surrogate

Exclusion Criteria

•Clinical criteria
•Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.
•Baseline platelet count \< 50000/µL.
•Baseline blood glucose of \< 50mg/dL or \>400mg/dl.
•Severe, sustained hypertension (SBP \> 220 mm Hg or DBP \> 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.
•Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
•Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
•Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
•History of life threatening allergy (more than rash) to contrast medium.
•Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery .

Outcomes

Primary Outcomes

Difference in proportion of patients achieving favorable outcomes (defined as mRS 0-3) at 90 days

Time Frame: 90 days

The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])

Secondary Outcomes

Dramatic early favorable response(24 (-2/+12) hours)
Quality of life analysis as measured by EuroQol Five Dimensions (EuroQol/EQ-5D)(90 days)
Difference in proportion of patients with mRS 0-2 scores between the two groups at 12 months.(12 months)
Barthel Index at 90 days(90 days)
Dichotomized mRS score (0-2 versus 3-6 )(90 days)
Ordinal Shift analysis of mRS at 90 days(90 days)
Proportion of basilar artery recanalization(24-72 hours (both treatment groups); post procedure immediately (thrombectomy arm))
Difference in proportion of patients with mRS 0-3 scores between the two groups at 12 months.(12 months)