Acute Mild Ischemic Stroke, Basilar Artery Occlusion, Extended Time Window, Rescue Endovascular Treatment
Conditions
Brief summary
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. 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
PROCEDUREEndovascular 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.
Sponsors
First Affiliated Hospital of Wannan Medical College
The First Affiliated Hospital of the University of Science and Technology of China
First People's Hospital of Yulin
THE SECOND PEOPLE'S HOSPITAL, WUHU
People's Hospital of Guoyang County
Heyuan people's Hospital
The First Affiliated Hospital of Hainan Medical University
Wuwei City People's Hospital
People's Hospital of Lixin Country
Zhongshan Hospital Of Traditional Chinese Medicine
Xihua People's Hospital
Wuhan No.1 Hospital
The Fourth Hospital of Liuan
Huaibei Miner General Hospital, Huaibei, China.
Guangdong Second Provincial General Hospital
The First Affiliated Hospital of University of South China
Maoming Hospital of Traditional Chinese Medicine
People's Hospital of Linquan County
Jiangsu Province Hospital of Traditional Chinese Medicine
Haiyan People's Hospital
Haiyan County People's Hospital
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Yingshang County People's Hospital
The second affiliated hospital of Xuzhou medical university
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization. | 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. |
| Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization. | 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. |
| Change in NIHSS score from pre-randomization baseline at 24 hours after randomization. | 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. |
| EQ-5D-5L scale at 90 (±7) days after randomization. | 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. |
| Change in NIHSS score from pre-randomization baseline at 7±1 days after randomization or discharge. | Discharge or 7±1 days 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. |
| Successful reperfusion postoperatively. | At the end of the operation | 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. |
Countries
China
Contacts
CONTACTXianjun Huang, PhD
CONTACTWen Sun, PhD
Outcome results
None listed