Acute Ischemic StrokeNCT05903560
Radial Versus Femoral Access For Thrombectomy in Patients With Acute Basilar Artery Occlusion
A study testing endovascular recanalization via radial approach and endovascular recanalization via femoral approach in people with Acute Ischemic Stroke, run by Jinling Hospital, China at 1 site in China.
Trial summary
Stroke is one of the most important diseases endangering the health and quality of life of Chinese people. Acute ischemic stroke (AIS) is commonly caused by cerebrovascular stenosis or occlusion. The most effective treatment for AIS is timely and successful angiographic reperfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- endovascular recanalization via radial approach and endovascular recanalization via femoral approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2023to Sep 2026
- 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
- Acute ischemic stroke in the posterior circulation confirmed by symptoms and imaging examinations.
- Basilar artery occlusion confirmed by computed tomographic angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
- Age ≥ 18 years.
- Time from symptom onset to randomization within 24 hours of the estimated time of basilar artery occlusion.
- Baseline NIHSS score ≥ 10 before randomization.
- Intact dual circulation of the hand assessed by the modified Allen's test.
- Written informed consent from patients or their legally authorized representatives.
Who cannot join
- Pre-stroke disability with mRS score ≥ 3.
- Pregnant or lactating women.
- Allergic to contrast agents or nitinol devices.
- Participation in other clinical trials.
- Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110mmHg, and can not be controlled by antihypertensive drugs.
- Known genetic or acquired bleeding diathesis, lack of coagulation factors; or oral anticoagulant therapy with INR > 1.7.
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- Baseline lab values: blood glucose < 50mg/dL (2.8mmol/L) or > 400mg/dL (22.2 mmol/L), platelet count < 50*109 /L, or hematocrit < 25%.
- Life expectancy less than 1 year.
- Lost to follow-up within 90 days (e.g. no fixed residence, overseas patients, etc.).
- Acute ischemic stroke within 48 hours after percutaneous coronary intervention, cerebrovascular intervention, or major surgery (patients can be included if more than 48 hours).
- Clinical manifestations of central nervous system vasculitis.
- Premorbid nervous system diseases or mental disorders hindering the assessment of the disease.
- Diseases or anatomical abnormalities that make it difficult for radial or femoral artery puncture, sheath insertion or instrument delivery, such as local infection, anatomical abnormalities confirmed by ultrasound or other imaging examinations, previous interventional or open surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, Jinling Hospital
Nanjing, Jiangsu, 210002
Xinfeng Liu, MD, 02580860124, xfliu2@vip.163.com
About this study
Stroke is one of the most important diseases endangering the health and quality of life of Chinese people. Acute ischemic stroke (AIS) is commonly caused by cerebrovascular stenosis or occlusion. The most effective treatment for AIS is timely and successful angiographic reperfusion.
Due to the large diameter and obvious positioning of bilateral femoral arteries, the transfemoral artery (TFA) using Seldinger's technique has been the most commonly used approach for endovascular treatment. However, recent studies have suggested that the radial artery is an ideal puncture site for cerebrovascular intervention. Small sample studies have confirmed that endovascular recanalization for acute anterior circulation large vessel occlusion via TRA has been safe and effective. Still, there are some complex approaches needed to be converted to TFA. There has been no difference in total operation duration and fluoroscopy time between TRA and TFA, but the TRA group had higher radiation dose and shorter hospital stays than the TFA group. In addition, TRA tends to be more convenient than TFA, especially for posterior circulation lesions.
However, the current studies are based on a single center with a small sample size, and there has been still a lack of large-sample randomized controlled experiments to verify the safety and effectiveness of posterior endovascular recanalization via TRA.
Read the detailed description
In this trial, acute ischemic stroke patients with large vessel occlusion in the posterior circulation within 24 hours of symptom onset or last known well will be included. After screening and baseline evaluation, eligible subjects will be randomly assigned to one of the following 2 groups in a 1:1 ratio: The experimental group will undergo basilar artery recanalization via the radial artery approach, while the control group will through the femoral artery approach. The primary endpoint of this study is the favorable functional outcome at 90 days after the endovascular recanalization (defined as mRS ≤ 3). Subgroup analyses were prespecified for the primary outcome according to sex (male or female), age (<70 years or ≥70 years and <80 years or ≥80 years), baseline stroke severity (NIHSS score 10 to 19 or ≥20), time from the estimated time of basilar-artery occlusion to randomization (<6 hours or ≥6 hours), intravenous thrombolysis (no or yes), location of basilar-artery occlusion (proximal, middle, or distal), the presumed cause of the basilar-artery occlusion (large-artery atherosclerosis, cardioembolism, or undetermined and other determined cause), intracranial atherosclerotic disease as cause of stroke (yes or no), and PC-ASPECTS at baseline (<8 or ≥8).
- Conditions
- Acute Ischemic Stroke
- Being tested
- endovascular recanalization via radial approach, endovascular recanalization via femoral approach
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular recanalization via radial approachProcedure or surgery
Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach
endovascular recanalization via femoral approachProcedure or surgery
Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach
| Study group | Role | What they receive |
|---|---|---|
| the radial group | Experimental | Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach randomly Receives: Procedure: endovascular recanalization via radial approach |
| the femoral group | Active comparator | Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach randomly Receives: Procedure: endovascular recanalization via femoral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of favorable neurological function at 90 days (defined as mRS score ≤ 3)
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome)
Measured: 90 days after randomization
Secondary outcomes (11)
Procedure time
Procedure time of the endovascular thrombectomy
Measured: immediately after procedure
The proportion of mRS score 0-2 at 90 days
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Measured: 90 days after randomization
Ordinal distribution of mRS score at 90 days
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Measured: 90 days after randomization
Ordinal shift analysis of mRS at 90 days
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Measured: 90 days after randomization
Ordinal shift analysis of post-procedure PC-ASPECTS within 72 hours
PC-ASPECTS is short for posterior circulation Acute Stroke Prognosis Early Computed Tomography Score (ranging from 0 to 10, with a higher score indicating a better perfusion state).
Measured: whthin 72 hours after randomization
Ordinal shift analysis of post-procedure GCS score within 24 hours
GCS is short for Glasgow Coma Scale. GCS is a score of the degree of comma (range from 3 to 15, higher values indicate more severe comma).
Measured: 24 hours after randomization
Ordinal shift analysis of post-procedure NIHSS score within 24 hours
NIHSS is short for National Institute of Health stroke scale. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Measured: 24 hours after randomization
Ordinal shift analysis of post-procedure GCS score at 5-7 days
GCS is short for Glasgow Coma Scale. GCS is a score of the degree of comma (range from 3 to 15, higher values indicate more severe comma).
Measured: 5-7 days after randomization
Ordinal shift analysis of post-procedure NIHSS score at 5-7 days
NIHSS is short for National Institute of Health stroke scale. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Measured: 5-7 days after randomization
The value of Quality of Life (EQ-5D) at 90 days
EQ-5D is short for EuroQol Five Dimensions Questionnaire. EQ-5D is a five-dimension score (higher values indicate a worse prognosis).
Measured: 90 days after randomization
Barthel Index at 90 days
Barthel Index is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis).
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start22 Jul 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinfeng Liu, Jinling Hospital, China
- Investigators
- Xinfeng Liu, MD, Principal investigator, Department of Neurology, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903560
- Sponsor's protocol ID
- RACE-BAO
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Versus Femoral Access For Thrombectomy in Patients With Acute Basilar Artery Occlusion
- ClinicalTrials.gov ID
- NCT05903560
- Acronym / sponsor ID
- RACE-BAO
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Jun 2023 (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.
Stroke is one of the most important diseases endangering the health and quality of life of Chinese people. Acute ischemic stroke (AIS) is commonly caused by cerebrovascular stenosis or occlusion. The most effective treatment for AIS is timely and successful angiographic reperfusion.
Due to the large diameter and obvious positioning of bilateral femoral arteries, the transfemoral artery (TFA) using Seldinger's technique has been the most commonly used approach for endovascular treatment. However, recent studies have suggested that the radial artery is an ideal puncture site for cerebrovascular intervention. Small sample studies have confirmed that endovascular recanalization for acute anterior circulation large vessel occlusion via TRA has been safe and effective. Still, there are some complex approaches needed to be converted to TFA. There has been no difference in total operation duration and fluoroscopy time between TRA and TFA, but the TRA group had higher radiation dose and shorter hospital stays than the TFA group. In addition, TRA tends to be more convenient than TFA, especially for posterior circulation lesions.
However, the current studies are based on a single center with a small sample size, and there has been still a lack of large-sample randomized controlled experiments to verify the safety and effectiveness of posterior endovascular recanalization via TRA.
Detailed description
In this trial, acute ischemic stroke patients with large vessel occlusion in the posterior circulation within 24 hours of symptom onset or last known well will be included. After screening and baseline evaluation, eligible subjects will be randomly assigned to one of the following 2 groups in a 1:1 ratio: The experimental group will undergo basilar artery recanalization via the radial artery approach, while the control group will through the femoral artery approach. The primary endpoint of this study is the favorable functional outcome at 90 days after the endovascular recanalization (defined as mRS ≤ 3). Subgroup analyses were prespecified for the primary outcome according to sex (male or female), age (<70 years or ≥70 years and <80 years or ≥80 years), baseline stroke severity (NIHSS score 10 to 19 or ≥20), time from the estimated time of basilar-artery occlusion to randomization (<6 hours or ≥6 hours), intravenous thrombolysis (no or yes), location of basilar-artery occlusion (proximal, middle, or distal), the presumed cause of the basilar-artery occlusion (large-artery atherosclerosis, cardioembolism, or undetermined and other determined cause), intracranial atherosclerotic disease as cause of stroke (yes or no), and PC-ASPECTS at baseline (<8 or ≥8).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the radial group | Experimental | Procedure: endovascular recanalization via radial approachPatients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach randomly |
| the femoral group | Active comparator | Procedure: endovascular recanalization via femoral approachPatients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach randomly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute ischemic stroke in the posterior circulation confirmed by symptoms and imaging examinations.
- Basilar artery occlusion confirmed by computed tomographic angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
- Age ≥ 18 years.
- Time from symptom onset to randomization within 24 hours of the estimated time of basilar artery occlusion.
- Baseline NIHSS score ≥ 10 before randomization.
Key exclusion criteria (13 listed)
- Pre-stroke disability with mRS score ≥ 3.
- Pregnant or lactating women.
- Allergic to contrast agents or nitinol devices.
- Participation in other clinical trials.
- Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110mmHg, and can not be controlled by antihypertensive drugs.
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 recanalization via radial approachPatients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach | Procedure or surgery | the radial group |
| endovascular recanalization via femoral approachPatients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach | Procedure or surgery | the femoral group |
Primary outcome
The proportion of favorable neurological function at 90 days (defined as mRS score ≤ 3)
Time frame: 90 days after randomization
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome)
11 secondary outcomes
Procedure time
Time frame: immediately after procedure
The proportion of mRS score 0-2 at 90 days
Time frame: 90 days after randomization
Ordinal distribution of mRS score at 90 days
Time frame: 90 days after randomization
Ordinal shift analysis of mRS at 90 days
Time frame: 90 days after randomization
Ordinal shift analysis of post-procedure PC-ASPECTS within 72 hours
Time frame: whthin 72 hours after randomization
Ordinal shift analysis of post-procedure GCS score within 24 hours
Time frame: 24 hours after randomization
Ordinal shift analysis of post-procedure NIHSS score within 24 hours
Time frame: 24 hours after randomization
Ordinal shift analysis of post-procedure GCS score at 5-7 days
Time frame: 5-7 days after randomization
Ordinal shift analysis of post-procedure NIHSS score at 5-7 days
Time frame: 5-7 days after randomization
The value of Quality of Life (EQ-5D) at 90 days
Time frame: 90 days after randomization
Barthel Index at 90 days
Time frame: 90 days after randomization
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 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Xinfeng Liu, MD principal investigator
Department of Neurology, Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endovascular recanalization via radial approach and endovascular recanalization via femoral approach in people with Acute Ischemic Stroke, run by Jinling Hospital, China at 1 site 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 7 inclusion and 13 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Rui Liu, MD (+86 2584801861, liurui8616@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of favorable neurological function at 90 days (defined as mRS score ≤ 3) (time frame: 90 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 30 Apr 2026.