About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pre-stroke disability with mRS score ≥ 3.
Pregnant or lactating women.
Allergic to contrast agents or nitinol devices.
Participation in other clinical trials.
Trial design
Parallel
Treatments tested in this trial
endovascular recanalization via radial approach
Procedure/SurgeryPatients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach
endovascular recanalization via femoral approach
Procedure/SurgeryPatients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Procedure time
Procedure time of the endovascular thrombectomy
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).
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).
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).
Other outcomes
The rate of successful cerebrovascular angiography
Whether the diagnostic cerebrovascular angiography is finished successfully.
The rate of successful vascular recanalization (defined as mTICI 2b/c)
mTICI is short for modified Thrombolysis in cerebral Infarction (ranging from 0 to 3, with higher values indicating a better reperfusion state).
Time to first ambulation
The time until the patient could walk after the operation.
X-ray radiation dose
Radiation dose during the operation.
Sponsors and contacts
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