Skip to content

Observational Study of Hand Function After Distal Transradial Access for Angiography

RATATOUILLE Study (inteRnATional hAnd funcTiOn stUdy Following dIstaL radiaL accEss)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03789279
Acronym
RATATOUILLE
Enrollment
40
Registered
2018-12-28
Start date
2019-01-01
Completion date
2020-12-31
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nerve Injury, Radial Artery Occlusion

Keywords

Invasive coronary angiography, Distal transradial arterial access, Anatomical snuffbox, dTRA, dRA, Distal radial, Radial artery occlusion

Brief summary

Traditionally, coronary angiograms are performed through the radial artery which is accessed above the palm of the 'right' hand. In recent years, some cardiologists are performing this procedure from the back of the wrist in as the radial artery courses through the anatomical snuffbox (distal radial access). The aim of this study is to determine the prevalence of hand dysfunction following coronary angiography via the distal radial artery.

Detailed description

In this multi centre observational registry, we will recruit patients undergoing planned invasive coronary angiography. Inclusion criteria include: 1. Age ≥ 18 years. 2. The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound. 3. Patient should be able to comply with the protocol. 4. Provide written informed consent before study participation. The primary endpoint is the overall prevalence of hand dysfunction defined as any significant reduction from baseline score in any of the following five domains: DASH score Levine Katz score VAS score Sensory function Pinch grip strength. Specifically hand function will be assessed at 4 time points using simple tests of hand strength, sensation and ultrasound to assess the arterial latency.

Interventions

None listed

Sponsors

MC Zuiderzee
CollaboratorUNKNOWN
NHS National Waiting Times Centre Board
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥ 18 years. 2. The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound. 3. Patient should be able to comply with the protocol. 4. Provide written informed consent before study participation.

Exclusion criteria

1. Obligatory femoral or forearm radial access 2. Previous ipsilateral forearm radial artery occlusion. 3. Undergoing another procedure involving the ipsilateral radial artery, performed between the index procedure and the follow-up date. 4. Enrolment in another study that competes or interferes with this study. 5. Poor clinical condition like cardiogenic shock, that prohibits pre- and postprocedural function tests. 6. Any other condition which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study. 7. Co-morbidity that excludes patient follow-up.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of hand dysfunction1 monthAny significant deterioration from baseline in hand function according to the 5 studied domains.

Secondary

MeasureTime frameDescription
Vascular access complications (other than occlusion and bleeding)Day 0Surgical complications or clinically important vascular access complications
Puncture timeDay 0Time from skin puncture to successful placement of wire into the artery
Success of distal radial accessDay 0Successful introduction of sheath
Fluoroscopy timeDay 0Minutes
Hemostasis durationDay 0Minutes
Radial artery occlusion - including level of occlusion (prox/distal)0-12 monthsUSS guide

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026