RADIAL: Radial Artery Access

Sponsor
The Christie NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05768412
Collaborator
Terumo UK Ltd. (Other)
150
17

Study Details

Study Description

Brief Summary

This is an imaging investigation to assess the factors effecting radial artery diameter:
  • Patient demographics

  • Diameter change post standard care preparation

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radial Artery Access

Detailed Description

There are significant benefits to radial access intervention, namely superior mortality and morbidity Vs femoral access. In addition, there is significant patient preference and reduced nursing time post procedure in comparison to femoral access supporting day case practice.

Interventional oncology routinely involves repeated procedures therefore patient preference is a key factor in access choice. This again supports day case practice with significant patient preference also noted.

The clinical application of the study is to allow a broader spectrum of procedures to be performed via radial access. Currently due to a limited data available on factors effecting radial artery diameter practice there is a restriction on sheath size use. This limits the procedures that can be performed via this route. By assessing the diameter and factors which increase the vessel, larger access sheaths can be used opening up the procedure portfolio including neuro-interventional procedures and coeliac axis stenting. This will allow these procedures to be performed with added benefits of improved mortality/morbidity in addition patient preference.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Radial Artery Access: Demographic Factors Impacting Radial Artery Diameter
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
All patients

All patients undergoing Radial Artery Access requiring interventional radiology.

Procedure: Radial Artery Access
The radial artery is stabilized between the thumb and forefinger of the left hand and 1 to 2 mL of subcutaneous lidocaine is used to create a wheal over the zone of planned entry.

Outcome Measures

Primary Outcome Measures

  1. Radial Artery diameter [Before the procedure, during the procedure, and immediately after the procedure]

    The change in RA diameter during a standard of care RA access procedure performed by an interventional Radiologist before the procedure, during the procedure and immediately after the procedure and how this compares to patient demographics.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Aged 18 or over

  2. All patients undergoing Radial Artery Access requiring interventional radiology.

Exclusion Criteria:
  1. Prior history of radial artery occlusion

  2. Prior history of stroke

  3. Need for future dialysis access creation or preservation of upper extremity vasculature for patients with chronic kidney disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The Christie NHS Foundation Trust
  • Terumo UK Ltd.

Investigators

  • Principal Investigator: Pavan Najran, Dr, The Christie NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT05768412
Other Study ID Numbers:
  • CFTsp219
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Christie NHS Foundation Trust

Study Results

No Results Posted as of Mar 14, 2023