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

Detailed Description

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).

• 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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	90 days after randomization
Procedure time	Procedure time of the endovascular thrombectomy	immediately after procedure
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

Other Outcome Measures

Outcome Measure	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)	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

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 (Actual): July 22, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

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): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular 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