Comparing radial and femoral access for treating acute basilar artery occlusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of two different access methods, radial and femoral, for endovascular recanalization in patients suffering from acute ischemic stroke due to basilar artery occlusion. The trial aims to determine if the radial approach can provide similar or improved outcomes compared to the traditional femoral approach. Patients will be randomly assigned to receive treatment via either access method within 24 hours of symptom onset. The study will assess various outcomes including operation duration, fluoroscopy time, and safety measures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Neurology, Jinling Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Xinfeng Liu, MD — Department of Neurology, Jinling Hospital, China
• Study coordinator: Rui Liu, MD
• Email: liurui8616@163.com
• Phone: +86 2584801861

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.