Rescue Endovascular Treatment After Neurological Deterioration in Initially Mild Basilar Artery Occlusion in an Extended Time Window (RESCUE-BAO)

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.

Study Overview

• Status: Recruiting
• Conditions: Basilar Artery Occlusion; Acute Mild Ischemic Stroke; Rescue Endovascular Treatment; Extended Time Window
• Intervention / Treatment: Procedure: Endovascular Treatment

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. 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.

• Study Type: Interventional
• Enrollment (Estimated): 159
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen Sun, PhD; Phone Number: 8615050589620; Email: sunwen_medneuro@163.com
• Study Contact Backup: Name: Xianjun Huang, PhD; Phone Number: 8618130333940; Email: doctorhuangxj@hotmail.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of the University of Science and Technology of China
      • Contact: Wen Sun, PhD; Phone Number: +86 15050589620; Email: sunwen_medneuro@163.com
    • Wuhu, Anhui, China, 241000
      • Recruiting
      • First Affiliated Hospital of Wannan Medical College
      • Contact: Xianjun Huang, PhD; Phone Number: 8618130333940

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovascular Therapy Group; Researchers can choose to deal with the stenosis or occlusion of blood vessels according to their own judgment, including stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.	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 occlusion, it is necessary to navigate the catheter through the proximal stenosis or occlusion to access the intracranial occlusion. Researchers have the discretion to treat the stenotic or occluded vessels, which may include options such as no treatment, stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
No Intervention: Best Medical Management Group; Participants receive best medical management only. Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy, no intra-arterial treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization.	The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.	90 (±7)days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful reperfusion postoperatively.	The eTICI (extended Thrombolysis in Cerebral Infarction) score is a standard used to evaluate the degree of reperfusion in acute ischemic stroke patients following endovascular therapy (EVT). It is a further refinement of the mTICI (modified TICI) score.	At the end of the operation
Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization.	Shift analysis is a statistical method used to evaluate the overall distribution change in modified Rankin Scale (mRS) scores, assessing whether an intervention leads to a general shift toward better outcomes across all score categories.	90 (±7) days after randomization
Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization.	The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.	90 (±7) days after randomization
EQ-5D-5L scale at 90 (±7) days after randomization.	The EQ-5D-5L scale is a standardized tool used to measure a person's health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels to indicate the severity of problems in those areas.	90 (±7) days after randomization
Change in NIHSS score from pre-randomization baseline at 24 hours after randomization.	The NIHSS (National Institutes of Health Stroke Scale) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The score helps in gauging the degree of impairment caused by a stroke.	24 hours after randomization
Change in NIHSS score from pre-randomization baseline at 7±1 days after randomization or discharge.	The NIHSS (National Institutes of Health Stroke Scale) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The score helps in gauging the degree of impairment caused by a stroke.	Discharge or 7±1 days after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 90 (±7) days after randomization.	All-cause mortality refers to the rate of death from any cause within a specific time period, without considering the underlying cause of death.	90 (±7) days after randomization
Incidence of symptomatic intracerebral haemorrhage (sICH) within 48 hours after randomization (Heidelberg bleeding classification).	Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 48 hours of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma. The sICH was defined as ICH associated with a worsening of 4 or more points on the NIHSS or resulting in death, and cerebral herniation, which were not present at baseline.	Within 48 hours after randomization.
Incidence of any intracerebral haemorrhage within 48 hours after randomization (Heidelberg bleeding classification).	Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 48 hours of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma.	within 48 hours after randomization

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wannan Medical College
• Collaborators: Jiangsu Province Hospital of Traditional Chinese Medicine; The First Affiliated Hospital of University of South China; Guangdong Second Provincial General Hospital; Wuhan No.1 Hospital; First People's Hospital of Yulin; The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine; Zhongshan Hospital Of Traditional Chinese Medicine; The First Affiliated Hospital of Hainan Medical University; Haiyan County People's Hospital; Haiyan People's Hospital; Heyuan people's Hospital; Xihua People's Hospital; The second affiliated hospital of Xuzhou medical university; THE SECOND PEOPLE'S HOSPITAL, WUHU; People's Hospital of Lixin Country; People's Hospital of Guoyang County; Maoming Hospital of Traditional Chinese Medicine; The Fourth Hospital of Liuan; Wuwei City People's Hospital; Huaibei Miner General Hospital, Huaibei, China.; The First Affiliated Hospital of the University of Science and Technology of China; People's Hospital of Linquan County; Yingshang County People's Hospital; The Central Hospital of Wuhan, Wuhan, Hubei, China; Suixi County Hospital of Traditional Chinese Medicine; Affiliated Jinling Hospital, Medical School of Nanjing University; Xiangtan Central Hospital, Xiangtan, Hunan, China; Feidong County Hospital of Traditional Chinese Medicine, Hefei, Anhui, China; Dongguan People's Hospital, Dongguan, Guangdong, China

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 12, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia; Arterial Occlusive Diseases
• Other Study ID Numbers: RESCUE-BAO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No