Comparing radial and femoral access for treating acute basilar artery occlusion

Radial Versus Femoral Access For Thrombectomy in Patients With Acute Basilar Artery Occlusion

This study is testing whether using a wrist (radial) access instead of a groin (femoral) access for treating a specific type of stroke can lead to better results for patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 386 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jinling Hospital, China (other)
• Drugs / interventions: radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05903560 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with acute ischemic stroke in the posterior circulation and confirmed basilar artery occlusion.

Not a fit: Patients with pre-stroke disabilities, severe hypertension, or those participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with acute ischemic stroke, potentially enhancing recovery outcomes.

How similar studies have performed: Previous studies have shown promising results for the radial approach in similar interventions, suggesting potential for success in this trial.

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.

Where this trial is running

Nanjing, Jiangsu

• 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

Conditions: Acute Ischemic Stroke