Biplanar Handheld Ultrasound for Transradial Artery Puncture

NCT07708532 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Fourth People's Hospital Tongji University

Phase

Not applicable

Started

2026-04-01

Last updated

2026-07-16

Condition(s) studied

Radial Artery Cannulation

Investigational drug(s) / intervention(s)

Biplanar handheld ultrasound systemConventional high-frequency linear-array ultrasound system

Biplanar handheld ultrasound system: A biplanar handheld ultrasound system used to guide radial artery puncture. Its T-shaped dual-probe configuration provides simultaneous long-axis and short-axis views of the radial artery and puncture needle.

Conventional high-frequency linear-array ultrasound system: A conventional high-frequency linear-array ultrasound system used to guide radial artery puncture using either a short-axis out-of-plane technique or a long-axis in-plane technique.

Study summary

Radial artery puncture is commonly used to obtain vascular access for cerebral angiography and neurointerventional procedures. Conventional ultrasound guidance usually provides either a short-axis or a long-axis view of the radial artery. A biplanar handheld ultrasound system can provide simultaneous long-axis and short-axis views, which may help the operator visualize the puncture needle and radial artery more clearly.

This prospective, single-center, randomized, parallel-group superiority trial will compare the TUOREN biplanar handheld ultrasound system with a conventional high-frequency linear-array ultrasound system for ultrasound-guided radial artery puncture. A total of 152 adults scheduled to undergo cerebral angiography or neurointerventional treatment through a transradial approach will be randomly assigned in a 1:1 ratio to one of the two ultrasound-guidance groups.

The main objective is to determine whether biplanar handheld ultrasound guidance improves the percentage of participants with successful radial artery cannulation on the first puncture attempt. Other assessments include the total number of puncture attempts, cumulative active puncture time, fixation time after successful cannulation, and the occurrence of posterior wall puncture.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Adults aged 18 years or older, regardless of sex, who are scheduled to undergo cerebral angiography or neurointerventional treatment through a transradial approach. 2. Adequate collateral circulation between the radial and ulnar arteries, as demonstrated by the modified Allen test or vascular ultrasound. 3. Radial artery diameter of at least 1.5 mm on preprocedural ultrasound examination. 4. Ability to understand the study procedures, willingness to participate voluntarily, and provision of written informed consent. Exclusion Criteria: 1. Infection or skin damage at the intended puncture site; known radial artery occlusion or severe stenosis; or inadequate collateral circulation between the radial and ulnar arteries. 2. Radial artery diameter of less than 1.5 mm on preprocedural ultrasound examination, or severe radial artery tortuosity or anatomical variation that may interfere with the puncture procedure. 3. Previous puncture, surgery, or trauma involving the radial artery on the intended puncture side that may have altered the local anatomy. 4. Hemodynamic instability requiring urgent hemodynamic support, including cardiogenic shock or severe hypotension. 5. Impaired consciousness, psychiatric illness, or any other condition that prevents the participant from cooperating with the study procedures or completing the required follow-up. 6. Severe coagulation abnormality, defined as an international normalized ratio greater than 1.8 or a platelet count below 80 × 10\^9/L.

Primary outcome measure(s)

First-attempt success rate — During the puncture procedure
Proportion of participants with successful radial artery cannulation on the first continuous puncture attempt. Success is confirmed by sustained blood return guidewire advancement at least 5 to 10 cm without resistance and an arterial pressure waveform after catheter connection.

Trial sites (1)

Facility	City	Region	Status
Shanghai Fourth People's Hospital	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07708532 on ClinicalTrials.gov ↗ ← All trials in China