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

Overview

A prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window.

Detailed description

This trial aims to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window. The study used a stratified block randomization method, with stratification by center. A central randomization system was used to assign subjects to the experimental group and the control group in a 2:1 ratio for each center.

Interventions

• Procedure Endovascular Treatment
  Neurointerventionist determine whether to proceed with interventional therapy after assessing the location and degree of occlusion, the tortuosity of the access vessel, and the presence of stenosis or occlusion in the proximal artery. In cases where there is no proximal stenosis or occlusion, mechanical thrombectomy is performed, and the specific thrombectomy strategy is tailored by the researcher based on the patient's condition. For lesions associated with proximal vascular stenosis or occlusi

Primary outcome measures

• 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]

Secondary outcome measures (6)

• 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]
• 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 NIHSS score from baseline at 24 hours postoperatively. [Time frame: 24 hours after procedure]
• EQ-5D-5L scale at 90 (±7) days after randomization. [Time frame: 90 (±7) days after procedure]
• Change in 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

• Age ≥18 years.
• Symptoms and signs consistent with basilar artery ischemia.
• 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.
• First-time onset meeting the criteria for mild ischemic stroke diagnosis: NIHSS score <6.
• Symptom progression within 7 days of the first onset.
• Symptom progression: NIHSS score increase ≥4 points or consciousness level increase ≥2 points from the initial NIHSS score.
• Time from symptom onset to randomization >24 hours.
• Symptom progression to randomization time ≤24 hours.
• NIHSS score ≥10 before randomization.
• pc-ASPECTS before randomization ≥ 6
• 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

• 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).
• mRS >2.
• Factors in the target vessel that are expected to prevent completion of endovascular treatment.
• Multiple vessel occlusions.
• Prior imaging confirmed or investigator-assessed chronic basilar artery occlusion.
• Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
• Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
• Gastrointestinal or urinary tract bleeding, acute myocardial infarction, cranial trauma, or major surgery within the past month.
• Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
• Platelet count <40×10\^9/L, or INR >2 during anticoagulation therapy (irreversible).
• Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
• Known allergy to iodine contrast agents or other treatment-related drugs.
• 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).
• Uncontrollable blood glucose <2.8 mmol/L or >22.2 mmol/L.
• Pregnancy or breastfeeding.
• Life expectancy <6 months.
• Participation in other clinical studies that may affect outcome assessment.
• 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 Wannan Medical College — Wuhu

Identifiers

NCT: NCT06843356 · RESCUE-BAO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗