ClinicalTrials.gg
CompletedNCT07928960SoundDistalUpdated Nov 10, 2026

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

An interventional study of echo guided puncture and conventional puncture in Percutaneous Coronary Intervention, sponsored by CHU Helora Jolimont. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by CHU Helora Jolimont · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Nov 2024, registered Nov 2026).
Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Percutaneous Coronary Intervention

Keywords

  • dTRA
  • ultrasound-guided
03

In context

Lead sponsor

This is the only study on the registry with CHU Helora Jolimont as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (actual)

Study arms

  • Active comparator
    conventional puncture

    conventional puncture for TRA cannulation

    Procedure: conventional puncture

  • Experimental
    echo guided puncture

    echo guided puncture for TRA cannulation

    Procedure: echo guided puncture

Interventions

  • Procedureecho guided puncture

    echo guided puncture for PCI

  • Procedureconventional puncture

    conventional puncture for PCI

06

What researchers measure

Primary outcomes

  1. first-wiring pass success rate

    Time frame: from starting procedure to end of procedure

Secondary outcomes

  1. total number of attempts

    The total number of attempts needed for the first-wiring pass success rate. Attempts will be defined as puncture of the artery, confirmed by the back-bleeding through the needle hub but withdrawal of the needle, after failing the wiring.

    Time frame: from starting procedure to end of procedure

  2. time to access

    The time to access will be measured from the point of the first application of the operator's fingers or US probe to guide access to a successful first-wiring pass success rate. For the blind puncture group: the first application of the operator's fingers on the artery to palpate it.

    Time frame: from starting procedure to end of procedure

  3. Bleeding

    Puncture site bleeding according to EASY criteria and Overall bleeding according to BARC criteria

    Time frame: from starting procedure to end of procedure

  4. Successful sheath insertion

    Time frame: from starting procedure to end of procedure

  5. crossover

    Crossover to US guidance and/or Access site cross-over

    Time frame: from starting procedure to end of procedure

  6. Vascular access-site complication

    Time frame: from starting procedure to end of procedure

  7. Distal radial artery occlusion

    Time frame: from starting procedure to discharge

  8. Hemostasis time

    Time frame: from starting procedure to end of procedure

  9. Pain associated with the procedure

    Time frame: from starting procedure to discharge

07

Study locations

1 site
  • CHU HELORA - Hôpital de Jolimont
    La Louvière, 7100, Belgium
08

References and documents

Publications

  • Hadjivassiliou A, Kiemeneij F, Nathan S, Klass D. Ultrasound-guided access to the distal radial artery at the anatomical snuffbox for catheter-based vascular interventions: a technical guide. EuroIntervention. 2021 Mar 19;16(16):1342-1348. doi: 10.4244/EIJ-D-19-00555. PubMed 31380781 ↗
  • Mori S, Hirano K, Yamawaki M, Kobayashi N, Sakamoto Y, Tsutsumi M, Honda Y, Makino K, Shirai S, Ito Y. A Comparative Analysis between Ultrasound-Guided and Conventional Distal Transradial Access for Coronary Angiography and Intervention. J Interv Cardiol. 2020 Sep 8;2020:7342732. doi: 10.1155/2020/7342732. eCollection 2020. PubMed 32982609 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07928960
Lead sponsor
CHU Helora Jolimont
Responsible party
Sponsor
First posted
Nov 10, 2026
Start date
Nov 18, 2024
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026
Last update
Nov 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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