Biplanar Handheld Ultrasound for Transradial Artery Puncture

NCT07708532 | Active Not Recruiting

• 1 other identifier: 2026027-001
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radial Artery Cannulation

Keywords

Ultrasound-guided radial artery cannulation; Biplanar ultrasound; Handheld ultrasound; Transradial access; Vascular access; First-attempt success; TUOREN biplanar handheld ultrasound

Outcome Measures

Primary Outcomes (1)

• First-attempt success rate

  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.

  During the puncture procedure

Secondary Outcomes (7)

• Mean total number of puncture attempts required for successful radial artery cannulation

  From initial needle-to-skin contact until confirmation of successful radial artery cannulation during the index procedure

• Mean cumulative active puncture time to successful radial artery cannulation

  From initial needle-to-skin contact until confirmation of successful radial artery cannulation during the index procedure

• Mean time required for catheter fixation after successful radial artery cannulation

  From confirmation of successful radial artery cannulation until completion of catheter fixation and dressing during the index procedure

• Percentage of participants with posterior wall puncture

  From the first puncture attempt until confirmation of successful radial artery cannulation during the index procedure

• Mean systolic blood pressure before the first puncture attempt

  Within 1 minute before the first puncture attempt of the index procedure

Study Arms (2)

TUOREN Biplanar Handheld Ultrasound Guidance

EXPERIMENTAL

Participants assigned to this arm will undergo transradial artery puncture guided by TUOREN biplanar handheld ultrasound which provides simultaneous long-axis and short-axis views.

Device: Biplanar handheld ultrasound system

Conventional Ultrasound Guidance

ACTIVE COMPARATOR

Participants assigned to this arm will undergo transradial artery puncture guided by a conventional high-frequency linear array ultrasound probe using short-axis out-of-plane or long-axis in-plane techniques.

Device: Conventional high-frequency linear-array ultrasound system

Interventions

Biplanar handheld ultrasound system DEVICE

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.

TUOREN Biplanar Handheld Ultrasound Guidance

Conventional high-frequency linear-array ultrasound system DEVICE

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.

Conventional Ultrasound Guidance

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older, regardless of sex, who are scheduled to undergo cerebral angiography or neurointerventional treatment through a transradial approach.
• Adequate collateral circulation between the radial and ulnar arteries, as demonstrated by the modified Allen test or vascular ultrasound.
• Radial artery diameter of at least 1.5 mm on preprocedural ultrasound examination.
• Ability to understand the study procedures, willingness to participate voluntarily, and provision of written informed consent.

You may not qualify if:

• 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.
• 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.
• Previous puncture, surgery, or trauma involving the radial artery on the intended puncture side that may have altered the local anatomy.
• Hemodynamic instability requiring urgent hemodynamic support, including cardiogenic shock or severe hypotension.
• Impaired consciousness, psychiatric illness, or any other condition that prevents the participant from cooperating with the study procedures or completing the required follow-up.
• Severe coagulation abnormality, defined as an international normalized ratio greater than 1.8 or a platelet count below 80 × 10\^9/L.

Sponsors & Collaborators

• Shanghai Fourth People's Hospital Tongji University: lead

Study Sites (1)

Shanghai Fourth People's Hospital

Shanghai, Shanghai Municipality, 200435, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because the two ultrasound systems are visibly different, the operator and the on-site observer recording puncture attempts and procedure times cannot be masked. Posterior wall puncture may be independently adjudicated using coded ultrasound recordings by an assessor without access to the allocation list.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-center, prospective, randomized, parallel-group superiority trial. Participants will be randomized in a 1:1 ratio using block randomization with allocation concealment to undergo transradial artery puncture guided by either a biplanar handheld ultrasound system or a conventional high-frequency linear-array ultrasound system. Each participant will receive only the assigned ultrasound-guidance method during the index procedure.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)