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New treatment option for Acute Ischemic Stroke
Official title Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window
ClinicalTrials.gov ID: NCT06560203
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Posterior circulation acute ischemic stroke within 24-72 hours from symptom onset/last seen well (except for isolated vertigo), where patient is...
- 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 ≤ 80.
- Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points.
- No significant pre-stroke functional disability (mRS ≤ 1).
You likely can't join if
- Clinical criteria
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0.
- Baseline platelet count \< 50000/µL.
- Baseline blood glucose of \ 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...
- Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
See the full eligibility 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...
- 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 ≤ 80.
- 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...
- Informed consent obtained from patient or authorized patient surrogate
- Clinical criteria
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0.
- Baseline platelet count \< 50000/µL.
- Baseline blood glucose of \ 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...
- 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 .
- Renal insufficiency with creatinine ≥ 3 mg/dl.
- Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
- Subject participating in a study involving an investigational drug or device that would impact this study.
- Known diagnosis or clinical suspicion of cerebral vasculitis.
- 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...
- Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
- 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
- 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.
- CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
- Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
- Complete bilateral thalamic infarction on CT or MRI.
- 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...
- people with occlusions in both anterior and posterior circulation.
- Evidence of intracranial tumor (except small meningioma).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.