EVT in Acute Basilar Artery Occlusion With Large Infarction Core
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endovascular Treatment.
- Who it may be relevant to
- Registry conditions: Basilar Artery Occlusion, Large Ischemic Core, Large Core Infarct, Endovascular Treatments. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Trial of Endovascular Treatment in Acute Basilar Artery Occlusion Patients With a Large Infarct Core
Overview
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.
Detailed description
This trial aims to evaluate whether best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone improves neurological outcomes in acute basilar artery occlusion (BAO) patients with large infarct cores. A centralized 1:1 simple randomization design assigns participants to receive either EVT or BMM based on randomization results.
Interventions
- Procedure Endovascular Treatment
The vascular access route is selected based on the patient's anatomical characteristics and operator discretion. Endovascular treatment (EVT) procedures must adhere to each participating center's standardized operating protocols. Upon confirmation of vascular occlusion, EVT may be performed using devices approved by China's National Medical Products Administration (NMPA). Based on lesion-specific features and operator judgment, permissible techniques include stent retriever thrombectomy, aspirat
Primary outcome measures
- Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization. [Time frame: 90 (±7) days after procedure]
Secondary outcome measures (5)
- Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization. [Time frame: 90 (±7)days after procedure]
- Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization. [Time frame: 90 (±7) days after procedure]
- Change in POST-NIHSS score from baseline at 24 hours postoperatively. [Time frame: 24 hours after procedure]
- Change in POST-NIHSS score from baseline at discharge or 5-7 days postoperatively. [Time frame: Discharge or 5 -7 days after procedure.]
- Successful reperfusion postoperatively. [Time frame: At the end of the operation]
Eligibility criteria
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, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
8\. Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
9\. Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
10\. Known allergy to iodine contrast agents or other treatment-related drugs. 11. Medically uncontrolled refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) (Note: Participants can be included if their blood pressure is controllable with medication and maintained at an acceptable level).
12\. Uncontrollable blood glucose <2.8 mmol/L or >22.2 mmol/L. 13. Pregnancy or breastfeeding. 14. Life expectancy <6 months. 15. Participation in other clinical studies that may affect outcome assessment. 16. Investigator's judgment that the patient is unsuitable for participation in this study or may face significant risks (e.g., due to mental illness, cognitive, or emotional disorders preventing understanding and/or compliance with study procedures and/or follow-up).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- First Affiliated Hospital of Hainan Medical University — Haikou
Identifiers
NCT: NCT07090941 · BOLT