Acute Mild Ischemic StrokeRESCUE-BAONCT06843356
Rescue Endovascular Treatment After Neurological Deterioration in Initially Mild Basilar Artery Occlusion in an Extended Time Window
A study testing Endovascular Treatment in people with Acute Mild Ischemic Stroke and Basilar Artery Occlusion, run by First Affiliated Hospital of Wannan Medical College at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Mild Ischemic Stroke, Basilar Artery Occlusion, Rescue Endovascular Treatment
- What is being tested?
- Endovascular Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Initially mild ischemic stroke, defined as an initial NIHSS score <6, with no prior endovascular treatment for the index ischemic event.
- 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.
- 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.
- 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.
- Posterior circulation Acute Stroke Prognosis Early CT Score (pc-ASPECTS) ≥6 on noncontrast CT or diffusion-weighted MRI performed after qualifying neurological deterioration.
- Time from qualifying neurological deterioration to randomization ≤24 hours.
- Written informed consent obtained from the patient or a legally authorized representative.
Who cannot join
- 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).
- prestroke mRS >2.
- Factors in the target vessel that are expected to prevent completion of endovascular treatment.
- Concurrent anterior and posterior circulation strokes.
- Prior imaging confirmed or investigator-assessed chronic basilar artery occlusion.
- Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of the University of Science and Technology of China
Hefei, Anhui
Wen Sun, PhD, +86 15050589620, sunwen_medneuro@163.com
- Recruiting
First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000
Xianjun Huang, PhD, 8618130333940
About this study
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.
Read the 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.
- Conditions
- Acute Mild Ischemic Stroke, Basilar Artery Occlusion, Rescue Endovascular Treatment, Extended Time Window
- Being tested
- Endovascular Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Therapy Group | Experimental | 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. Receives: Procedure: Endovascular Treatment |
| Best Medical Management Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 (±7)days after randomization
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 24 hours 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.
Measured: 90 (±7) days 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.
Measured: Discharge or 7±1 days after randomization
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.
Measured: At the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Aug 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mild Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of the University of Science and Technology of China, First People's Hospital of Yulin, Wuhu City Second People's Hospital, People's Hospital of Guoyang County, Heyuan Shenhe 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 First 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843356
- Sponsor's protocol ID
- RESCUE-BAO
- Acronym
- RESCUE-BAO
- Status last verified
- Sep 2026
- First submitted
- 20 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Endovascular Treatment After Neurological Deterioration in Initially Mild Basilar Artery Occlusion in an Extended Time Window
- ClinicalTrials.gov ID
- NCT06843356
- Acronym / sponsor ID
- RESCUE-BAO / RESCUE-BAO
- Conditions
- Acute Mild Ischemic Stroke, Basilar Artery Occlusion, Rescue Endovascular Treatment, Extended Time Window
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of the University of Science and Technology of China, First People's Hospital of Yulin, Wuhu City Second People's Hospital, People's Hospital of Guoyang County, Heyuan Shenhe 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 First 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 start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Therapy Group | Experimental | Procedure: Endovascular TreatmentResearchers 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. |
| Best Medical Management Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Initially mild ischemic stroke, defined as an initial NIHSS score <6, with no prior endovascular treatment for the index ischemic event.
- 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.
- 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.
- 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.
Key exclusion criteria (18 listed)
- 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).
- prestroke mRS >2.
- Factors in the target vessel that are expected to prevent completion of endovascular treatment.
- Concurrent anterior and posterior circulation strokes.
- Prior imaging confirmed or investigator-assessed chronic basilar artery occlusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular TreatmentNeurointerventionist 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. | Procedure or surgery | Endovascular Therapy Group |
Primary outcome
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 randomization
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
6 secondary outcomes
Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization.
Time frame: 90 (±7) days after randomization
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 randomization
Change in NIHSS score from pre-randomization baseline at 24 hours after randomization.
Time frame: 24 hours after randomization
EQ-5D-5L scale at 90 (±7) days after randomization.
Time frame: 90 (±7) days after randomization
Change in NIHSS score from pre-randomization baseline at 7±1 days after randomization or discharge.
Time frame: Discharge or 7±1 days after randomization
Successful reperfusion postoperatively.
Time frame: At the end of the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Treatment in people with Acute Mild Ischemic Stroke and Basilar Artery Occlusion, run by First Affiliated Hospital of Wannan Medical College at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianjun Huang, PhD (8618130333940, doctorhuangxj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.