Acute Ischemic Stroke, Basilar Artery Occlusion
Conditions
Keywords
Mechanical thrombectomy, Extended time window
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.
Interventions
PROCEDUREMechanical thrombectomy
Neurointerventionist determine whether to proceed with interventional therapy after assessing the location and degree of occlusion, the tortuosity of the access vessel, and the presence of stenosis or occlusion in the proximal artery. In cases where there is no proximal stenosis or occlusion, mechanical thrombectomy is performed, and the specific thrombectomy strategy is tailored by the researcher based on the patient's condition. For lesions associated with proximal vascular stenosis or occlusion, it is necessary to navigate the catheter through the proximal stenosis or occlusion to access the intracranial occlusion. Researchers have the discretion to treat the stenotic or occluded vessels, which may include options such as no treatment, stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in proportion of patients achieving favorable outcomes (defined as mRS 0-3) at 90 days | 90 days | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ordinal Shift analysis of mRS at 90 days | 90 days | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]) |
| Quality of life analysis as measured by EuroQol Five Dimensions (EuroQol/EQ-5D) | 90 days | EuroQol Five Dimensions (EuroQol/EQ-5D) is a well-known and widely used health status instrument, and could be used to measure, compare and value health status across disease areas. |
| Difference in proportion of patients with mRS 0-2 scores between the two groups at 12 months. | 12 months | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]) |
| Proportion of basilar artery recanalization | 24-72 hours (both treatment groups); post procedure immediately (thrombectomy arm) | Vessel recanalization evaluated by CT angiography (CTA), MR Angiography (MRA) or conventional angiography at 24-72 hours in both treatment groups assessed by Arterial Occlusive Lesion（AOL) grades and adjudicated by a central core-lab. Vessel recanalization post procedure in the thrombectomy arm assessed by mTICI grades. Successful recanalization is defined as mTICI (Modified Thrombolysis in Cerebral Infarction) 2b or 3 on the post-procedure angiogram. |
| Difference in proportion of patients with mRS 0-3 scores between the two groups at 12 months. | 12 months | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]) |
| Dramatic early favorable response | 24 (-2/+12) hours | Dramatic early favorable response as determined by an National Institute of Health stroke scale (NIHSS) of 0-2 or NIHSS improvement ≥ 8 points at 24 (-2/+12) hours. |
| Dichotomized mRS score (0-2 versus 3-6 ) | 90 days | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]) |
| Barthel Index at 90 days | 90 days | An ordinal scale which measures a person's ability to complete activities of daily living (ADL). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events (SAE) | 90 days, 12 months, during follow-up | All SAE during follow-up in all randomized patients. |
| Symptomatic intracranial hemorrhage | 24-72 hours | Clinically significant ICH rates at 24-72 hours. All intracerebral hemorrhages will be classified by a central core-lab using the Heidelberg criteria. Symptomatic intracranial hemorrhage will be defined as per the following definition: deterioration in NIHSS score of ≥ 4 points and evidence of intraparenchymal hemorrhage type 2 in the 24 to 72 hours follow-up imaging scans. |
| Mortality | 90 days | Death |
Countries
China
Contacts
Primary ContactXunming Ji
Backup ContactChuanhui Li
Outcome results
None listed