Rescue treatment for mild ischemic stroke with basilar artery blockage

Trial of Rescue Endovascular Treatment for Progressive Acute Mild Ischemic Stroke With Basilar Artery Occlusion With Extended Time Window

This study is testing if combining a new type of treatment with standard care can help people with mild strokes caused by a blocked basilar artery feel better and recover more effectively.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 159 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Wannan Medical College (Academic / other)
• Locations: 1 site (Wuhu, Anhui)
• Trial ID: NCT06843356 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of combining best medical management with endovascular therapy in improving neurological outcomes for patients experiencing progressive acute mild ischemic stroke due to basilar artery occlusion. It is a multicenter, open-label, randomized controlled trial that uses a stratified block randomization method to assign participants to either the experimental group receiving endovascular treatment or the control group receiving standard medical management alone. The study focuses on patients who have experienced symptom progression within a specific time frame and have confirmed occlusion of the basilar or vertebral artery.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed basilar artery occlusion and progressive symptoms of mild ischemic stroke.

Not a fit: Patients who do not exhibit symptom progression or have a NIHSS score below the required threshold may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients suffering from mild ischemic strokes caused by basilar artery occlusion.

How similar studies have performed: While there have been studies on endovascular treatment for ischemic strokes, this specific approach within an extended time window is relatively novel and has not been extensively tested.

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), or digital subtraction angiography (DSA); if vertebral artery occlusion is present, it should completely block blood flow along the basilar artery.
4. First-time onset meeting the criteria for mild ischemic stroke diagnosis: NIHSS score \<6.
5. Symptom progression within 7 days of the first onset.
6. Symptom progression: NIHSS score increase ≥4 points or consciousness level increase ≥2 points from the initial NIHSS score.
7. Time from symptom onset to randomization \>24 hours.
8. Symptom progression to randomization time ≤24 hours.
9. NIHSS score ≥10 before randomization.
10. pc-ASPECTS before randomization ≥ 6
11. The patient or their family members are willing to comply with the protocol requirements and data collection procedures, understand, and sign the informed consent form.

Exclusion Criteria:

1. Symptom progression due to intracranial hemorrhage, brain edema, or other clear causes (including but not limited to infarct hemorrhagic transformation, new infarction in non-occluded vascular regions, severe infection, high fever, heart or kidney dysfunction, hypovolemia, or severe electrolyte disturbances).
2. mRS \>2.
3. Factors in the target vessel that are expected to prevent completion of endovascular treatment.
4. Multiple vessel occlusions.
5. Prior imaging confirmed or investigator-assessed chronic basilar artery occlusion.
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. Gastrointestinal or urinary tract bleeding, acute myocardial infarction, cranial trauma, or major surgery within the past month.
9. Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
10. Platelet count \<40×10\^9/L, or INR \>2 during anticoagulation therapy (irreversible).
11. Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
12. Known allergy to iodine contrast agents or other treatment-related drugs.
13. 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).
14. Uncontrollable blood glucose \<2.8 mmol/L or \>22.2 mmol/L.
15. Pregnancy or breastfeeding.
16. Life expectancy \<6 months.
17. Participation in other clinical studies that may affect outcome assessment.
18. 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).

Where this trial is running

Wuhu, Anhui

• First Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Xianjun Huang, PhD

Conditions Acute Mild Ischemic Stroke; Basilar Artery Occlusion; Rescue Endovascular Treatment; Extended Time Window