NCT05903560 Radial Versus Femoral Access For Thrombectomy in Patients With Acute Basilar Artery Occlusion
| NCT ID | NCT05903560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jinling Hospital, China |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 386 participants |
| Start Date | 2023-07-22 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 386 participants in total. It began in 2023-07-22 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Inclusion Criteria: 1. Acute ischemic stroke in the posterior circulation confirmed by symptoms and imaging examinations. 2. Basilar artery occlusion confirmed by computed tomographic angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA). 3. Age ≥ 18 years. 4. Time from symptom onset to randomization within 24 hours of the estimated time of basilar artery occlusion. 5. Baseline NIHSS score ≥ 10 before randomization. 6. Intact dual circulation of the hand assessed by the modified Allen's test. 7. Written informed consent from patients or their legally authorized representatives. Exclusion Criteria: 1. Pre-stroke disability with mRS score ≥ 3. 2. Pregnant or lactating women. 3. Allergic to contrast agents or nitinol devices. 4. Participation in other clinical trials. 5. Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110mmHg, and can not be controlled by antihypertensive drugs. 6. Known genetic or acquired bleeding diathesis, lack of coagulation factors; or oral anticoagulant therapy with INR \> 1.7. 7. 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%. 8. Life expectancy less than 1 year. 9. Lost to follow-up within 90 days (e.g. no fixed residence, overseas patients, etc.). 10. Acute ischemic stroke within 48 hours after percutaneous coronary intervention, cerebrovascular intervention, or major surgery (patients can be included if more than 48 hours). 11. Clinical manifestations of central nervous system vasculitis. 12. Premorbid nervous system diseases or mental disorders hindering the assessment of the disease. 13. 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.
Contact & Investigator
Xinfeng Liu, MD
PRINCIPAL INVESTIGATOR
Department of Neurology, Jinling Hospital, China
Frequently Asked Questions
Who can join the NCT05903560 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05903560 currently recruiting?
Yes, NCT05903560 is actively recruiting participants. Contact the research team at liurui8616@163.com for enrollment information.
Where is the NCT05903560 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05903560 clinical trial?
NCT05903560 is sponsored by Jinling Hospital, China. The principal investigator is Xinfeng Liu, MD at Department of Neurology, Jinling Hospital, China. The trial plans to enroll 386 participants.
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