Conventional or Ultrasound Guided Puncture Technique for the Distal Radial Artery, Direct Comparison Study (Sound Distal Trial).

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

600 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Over the last few years, a new approach using distal radial access had been employed for a various types of percutaneous interventions. The purpose was to further decrease the rate of vascular complications and proximal radial occlusion (RAO).

The feasibility of distal radial access in several specific groups of patients for conventional, complex coronary and non-coronary procedures was extensively studied and showed a variable rate of success between different operators, using different techniques. The main limitation is the rate of failure in cannulation that is related to the smaller diameter of the distal radial artery and the anatomic variability at the level of access site puncture. One of the solutions advocated by Hadjivassiliou et al. is the use of ultrasound-guided distal transradial acces (dTR)A, which is expected to reduce failure and complication rates.

A recent monocentric, single operator pilot study indicated a lower failure rate with ultrasound than conventional dTRA, without significant differences in puncture time and complication rate between the two approaches.

A specific ultrasound algorithm for distal radial puncture was recently developed and is currently used in our clinical daily practice, showing a 100% rate of success, in a selected group of patients that had favorable anatomic features. Imaging the distal radial artery by ultrasound could potentially be safer, select the proper candidates for this technique and increase the rate of successful cannulation. However, to date, the comparison of feasibility and safety between ultrasound-guided and conventional dTRA has not been reported.

The SOUND Distal trial is a pilot study measuring the reproducibility, rate of success, rate of complications and quality puncture measures.

The primary outcome is comparing the rate of success of dTRA cannulation between conventional and echo guided puncture. Secondary outcomes include quality puncture measures differences between the two approaches regarding patient scale pain/puncture time and number of attempts.

Other secondary end points include technic reproducibility among operators and the total rate of complications for both approaches.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Patient older than 18 years requiring diagnostic angiography or PCI.
• The subject has stable or acute coronary syndrome, or a positive functional study documenting ischemia.
• The subject is eligible for PCI.
• The subject is male, or a non-pregnant female.
• The subject gives consent prior to study inclusion.

Exclusion Criteria:

• Pregnant and/or breast-feeding females.
• Patients who intend to have a major surgical intervention within 6 months of enrolment in the study at the level of the vascular site access.
• Patients who previously participated in this study.
• The subject has suffered a stroke or transient ischemic neurological attack or cerebrovascular accident within the past six months, or has any known intracranial mass, arteriovenous malformation, aneurysm or other intracranial pathology.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

CHU Helora Jolimont

Study start

Nov 18, 2024 Actual

Primary completion

Nov 1, 2026 Actual

Study completion

Nov 1, 2026 Actual

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.