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

NCT05903560 | Recruiting

• 1 other identifier: RACE-BAO
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Procedure time

  immediately after procedure

• The proportion of mRS score 0-2 at 90 days

  90 days after randomization

• Ordinal distribution of mRS score at 90 days

  90 days after randomization

• Ordinal shift analysis of mRS at 90 days

  90 days after randomization

• Ordinal shift analysis of post-procedure PC-ASPECTS within 72 hours

  whthin 72 hours after randomization

Other Outcomes (6)

• The rate of successful cerebrovascular angiography

  immediately after procedure

• The rate of successful vascular recanalization (defined as mTICI 2b/c)

  Immediately after the thrombectomy procedure is completed

• Time to first ambulation

  within 90 days after randomization

Study Arms (2)

the radial group

EXPERIMENTAL

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

the femoral group

ACTIVE COMPARATOR

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

Interventions

endovascular recanalization via radial approach PROCEDURE

Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach

the radial group

endovascular recanalization via femoral approach PROCEDURE

Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach

the femoral group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke in the posterior circulation confirmed by symptoms and imaging examinations.
• Basilar artery occlusion confirmed by computed tomographic angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
• Age ≥ 18 years.
• Time from symptom onset to randomization within 24 hours of the estimated time of basilar artery occlusion.
• Baseline NIHSS score ≥ 10 before randomization.
• Intact dual circulation of the hand assessed by the modified Allen's test.
• Written informed consent from patients or their legally authorized representatives.

You may not qualify if:

• Pre-stroke disability with mRS score ≥ 3.
• Pregnant or lactating women.
• Allergic to contrast agents or nitinol devices.
• Participation in other clinical trials.
• Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110mmHg, and can not be controlled by antihypertensive drugs.
• Known genetic or acquired bleeding diathesis, lack of coagulation factors; or oral anticoagulant therapy with INR \> 1.7.
• 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%.
• Life expectancy less than 1 year.
• Lost to follow-up within 90 days (e.g. no fixed residence, overseas patients, etc.).
• Acute ischemic stroke within 48 hours after percutaneous coronary intervention, cerebrovascular intervention, or major surgery (patients can be included if more than 48 hours).
• Clinical manifestations of central nervous system vasculitis.
• Premorbid nervous system diseases or mental disorders hindering the assessment of the disease.
• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Department of Neurology, Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xinfeng Liu, MD

  Department of Neurology, Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Liu, MD

CONTACT

+86 2584801861; liurui8616@163.com

Xinfeng Liu, MD

CONTACT

+86 2584801861; xfliu2@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: July 22, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)