Radial Artery Access (RADIAL)

Radial Artery Access: Demographic Factors Impacting Radial Artery Diameter

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

• Patient demographics
• Diameter change post standard care preparation

Study Overview

• Status: Not yet recruiting
• Conditions: Radiology, Interventional
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Bryony Cotterell, Dr; Phone Number: 0161 446 3981; Email: bryony.cotterell@nhs.net
• Study Contact Backup: Name: Christie Sponsored Central Inbox; Phone Number: 0161 446 3981; Email: the-christie.sponsoredresearch@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients requiring Radial Artery Access at The Christie NHS Foundation Trust

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Artery diameter	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.	Before the procedure, during the procedure, and immediately after the procedure

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust
• Collaborators: Terumo UK Ltd.
• Investigators: Principal Investigator: Pavan Najran, Dr, The Christie NHS Foundation Trust

Publications and helpful links

General Publications

• Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, Ports TA, Boyle AJ. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol. 2013 Oct 3;168(3):2575-8. doi: 10.1016/j.ijcard.2013.03.048. Epub 2013 Apr 10.
• Boyer N, Beyer A, Gupta V, Dehghani H, Hindnavis V, Shunk K, Zimmet J, Yeghiazarians Y, Ports T, Boyle A. The effects of intra-arterial vasodilators on radial artery size and spasm: implications for contemporary use of trans-radial access for coronary angiography and percutaneous coronary intervention. Cardiovasc Revasc Med. 2013 Nov-Dec;14(6):321-4. doi: 10.1016/j.carrev.2013.08.009. Epub 2013 Oct 2.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: specialty; RADIOGRAPHY, INTERVENTIONAL is available for the diagnostic and therapeutic procedures
• Other Study ID Numbers: CFTsp219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Pending confirmation with funder and PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No