Rescue treatment for mild ischemic stroke with basilar artery blockage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years.
2. Initially mild ischemic stroke, defined as an initial NIHSS score \<6, with no prior endovascular treatment for the index ischemic event.
3. Basilar artery occlusion, or vertebral artery occlusion resulting in complete interruption of antegrade flow into the basilar artery, documented by CTA, MRA, or DSA during the initially mild phase and before qualifying neurological deterioration.
4. Qualifying neurological deterioration occurring between 24 hours and 7 days after initial symptom onset, or after the last known well if symptom onset is unknown.
5. Qualifying neurological deterioration is defined as an NIHSS score ≥10 with either a ≥4-point increase in total NIHSS or a ≥2-point increase in the NIHSS level-of-consciousness score from the initial NIHSS score and must be documented by certified medical personnel at a medical facility, including a referring hospital.
6. Posterior circulation Acute Stroke Prognosis Early CT Score (pc-ASPECTS) ≥6 on noncontrast CT or diffusion-weighted MRI performed after qualifying neurological deterioration.
7. Time from qualifying neurological deterioration to randomization ≤24 hours.
8. Written informed consent obtained from the patient or a legally authorized representative.

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, obstructive hydrocephalus, severe infection, high fever, heart or kidney dysfunction, hypovolemia, or severe electrolyte disturbances).
2. prestroke mRS \>2.
3. Factors in the target vessel that are expected to prevent completion of endovascular treatment.
4. Concurrent anterior and posterior circulation strokes.
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 it's running

• The First Affiliated Hospital of the University of Science and Technology of China
  Hefei, Anhui, China Recruiting
• First Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Recruiting

Study contacts

• Study coordinator: Xianjun Huang, PhD
• Email: doctorhuangxj@hotmail.com
• Phone: 8618130333940

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Endovascular Therapy for Basilar Artery Occlusion With Large Ischemic Core

  This trial tests whether adding endovascular therapy to standard medical care helps people with acute basilar artery occlusion and a large area of brain already affected.

  Recruiting The First Affiliated Hospital of University of Science and Technology of China · Hefei, Anhui · NCT07672795

• Basilar artery occlusion with large brain infarct: real-world endovascular vs medical therapy

  This registry follows adults with basilar artery occlusion and a large core infarct to see how endovascular therapy compares to medical management in routine care.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07345702

• Tenecteplase before transfer for basilar artery stroke 4.5–24 hours after symptom onset

  This trial tests whether giving IV tenecteplase before transfer helps people with basilar artery occlusion who are 4.5–24 hours from symptom onset and are being sent for thrombectomy.

  Recruiting Phase 4 Xuanwu Hospital, Beijing · Beijing · NCT07203625

• Endovascular treatment for acute basilar artery stroke with a large infarct core

  This trial will test whether adding endovascular clot removal to standard medical care helps adults with acute basilar artery occlusion who already have a large area of brain damage.

  Recruiting at 2 sites The First Affiliated Hospital of Hainan Medical University · Hefei, Anhui and 1 other locations · NCT07090941

• Comparing two methods for treating stroke caused by basilar artery blockage

  This study is testing two different methods for removing blood clots in the brain to see which one helps adults with stroke caused by a blocked basilar artery recover better.

  Recruiting at 4 sites Hopital Foch · Bordeaux and 11 other locations · NCT05320263

• Extending treatment options for stroke caused by basilar artery blockage

  This study is testing if a new treatment called tenecteplase can help people who have had a stroke from a blocked basilar artery feel better and recover more effectively compared to standard care.

  Recruiting at 13 sites Phase 2/3 University of Melbourne · Bankstown, New South Wales and 16 other locations · NCT05105633

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.