EVT in Acute Basilar Artery Occlusion With Large Infarction Core (NCT07090941) | Clinical Trial Compass
RecruitingNot Applicable
EVT in Acute Basilar Artery Occlusion With Large Infarction Core
China348 participantsStarted 2025-08-01
Plain-language summary
A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the efficacy and safety of best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone in acute basilar artery occlusion (BAO) patients with large infarct cores.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Age ≥18 years. 2. Symptoms and signs consistent with basilar artery ischemia. 3. Basilar artery or vertebral artery occlusion confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), digital subtraction angiography (DSA); if vertebral artery occlusion is present, it must completely obstruct blood flow to the basilar artery.
4\. POST-NIHSS score ≥10 at randomization. 5. Time from symptom onset to randomization ≤24 hours (symptom onset defined as last known well time).
6\. pc-ASPECTS of 3-5 on CT/MRI (for patients aged \<80 years) or pc-ASPECTS of 3-7 (for patients aged ≥80 years).
7\. Willingness of the patient or legally authorized representative to comply with protocol requirements and data collection procedures, with documented informed consent.
Exclusion Criteria:
* 1\. Pre-stroke modified Rankin Scale (mRS) score \>2. 2. Factors in the target vessel that are expected to prevent completion of endovascular treatment.
3\. Concurrent anterior and posterior circulation strokes or multivessel occlusions.
4\. Significant mass effect with imaging or clinical signs of obstructive hydrocephalus or tonsillar herniation.
5\. Basilar artery occlusion confirmed as chronic by prior imaging or investigator judgment.
6\. Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
7\. Intracranial hemorrhage within the past 6 months…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization.
Timeframe: 90 (±7) days after procedure
Trial details
NCT IDNCT07090941
SponsorThe First Affiliated Hospital of Hainan Medical University