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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Procedure: endovascular recanalization via radial approach; Procedure: endovascular recanalization via femoral approach

• Study Type: Interventional
• Enrollment (Estimated): 386
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rui Liu, MD; Phone Number: +86 2584801861; Email: liurui8616@163.com
• Study Contact Backup: Name: Xinfeng Liu, MD; Phone Number: +86 2584801861; Email: xfliu2@vip.163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Department of Neurology, Jinling Hospital
      • Contact: Xinfeng Liu, MD; Phone Number: 02580860124; Email: xfliu2@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the radial group; Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach randomly	Procedure: endovascular recanalization via radial approach; Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach
Active Comparator: the femoral group; Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach randomly	Procedure: endovascular recanalization via femoral approach; Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
favorable neurological function	favorable neurological function (defined as mRS score ≤ 3)	at 90 days post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Procedure time of the endovascular thrombectomy	at the operation 1 day

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Principal Investigator: Xinfeng Liu, MD, Department of Neurology, Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): July 22, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: RACE-BAO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No