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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular recanalization via radial approach | Procedure | Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 90 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | Procedure time of the endovascular thrombectomy | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of successful cerebrovascular angiography | Whether the diagnostic cerebrovascular angiography is finished successfully. | immediately after procedure |
| The rate of successful vascular recanalization (defined as mTICI 2b/c) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Liu, MD | Contact | +86 2584801861 | liurui8616@163.com | |
| Xinfeng Liu, MD | Contact | +86 2584801861 | xfliu2@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinfeng Liu, MD | Department of Neurology, Jinling Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Jinling Hospital | Recruiting | Nanjing | Jiangsu | 210002 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| endovascular recanalization via femoral approach | Procedure | Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach |
|
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 90 days after randomization |
mTICI is short for modified Thrombolysis in cerebral Infarction (ranging from 0 to 3, with higher values indicating a better reperfusion state).
| Immediately after the thrombectomy procedure is completed |
| Time to first ambulation | The time until the patient could walk after the operation. | within 90 days after randomization |
| X-ray radiation dose | Radiation dose during the operation. | immediately after procedure |
| Access site complications | Access site complications include: pseudoaneurysms requiring ultrasound-guided compression or thrombin injections or surgical treatment; hematoma requiring prolonged hospital stay; and limb ischemia and nerve injury adjacent to the blood vessels. | within 90 days from randomization |
| Hospital service costs | Total hospital service costs within hospitalization | From date of randomization until the date of discharge, assessed up to 10 months |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |