Clinical trial NCT06560203: Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Basilar Artery Occlusion
Keywords: Mechanical thrombectomy
Extended time window
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
3. Age ≥18 and ≤ 80.
4. Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points.
5. No significant pre-stroke functional disability (mRS ≤ 1).
6. 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.
7. Informed consent obtained from patient or authorized patient surrogate

Exclusion Criteria:

Clinical criteria

1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0.
2. Baseline platelet count \< 50000/µL.
3. Baseline blood glucose of \< 50mg/dL or \>400mg/dl.
4. 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.
5. Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
8. History of life threatening allergy (more than rash) to contrast medium.
9. Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery .
10. Renal insufficiency with creatinine ≥ 3 mg/dl.
11. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
12. Subject participating in a study involving an investigational drug or device that would impact this study.
13. Known diagnosis or clinical suspicion of cerebral vasculitis.
14. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.).
15. Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
16. Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial.

    Neuroimaging criteria
17. Hypodensity with a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) \< 6 and Pons-midbrain-index of ≥ 3 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
18. CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
19. Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
20. Complete bilateral thalamic infarction on CT or MRI.
21. Evidence of vertebral occlusion, high grade stenosis or arterial dissection in the extracranial or intracranial segment that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment.
22. Subjects with occlusions in both anterior and posterior circulation.
23. Evidence of intracranial tumor (except small meningioma).

Primary outcomes:
measure: Difference in proportion of patients achieving favorable outcomes (defined as mRS 0-3) at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Dramatic early favorable response
timeFrame: 24 (-2/+12) hours
measure: Dichotomized mRS score (0-2 versus 3-6 )
timeFrame: 90 days
measure: Ordinal Shift analysis of mRS at 90 days
timeFrame: 90 days
measure: Barthel Index at 90 days
timeFrame: 90 days
measure: Quality of life analysis as measured by EuroQol Five Dimensions (EuroQol/EQ-5D)
timeFrame: 90 days
measure: Difference in proportion of patients with mRS 0-2 scores between the two groups at 12 months.
timeFrame: 12 months
measure: Difference in proportion of patients with mRS 0-3 scores between the two groups at 12 months.
timeFrame: 12 months
measure: Proportion of basilar artery recanalization
timeFrame: 24-72 hours (both treatment groups); post procedure immediately (thrombectomy arm)
Other outcomes:
measure: Mortality
timeFrame: 90 days
measure: Symptomatic intracranial hemorrhage
timeFrame: 24-72 hours
measure: Serious adverse events (SAE)
timeFrame: 90 days, 12 months, during follow-up
Locations:
city: Beijing
country: China
facility: Xuanwu hospital
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xunming Ji
role: PRINCIPAL_INVESTIGATOR
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