Clinical trial NCT05768412: Radial Artery Access
Official title: Radial Artery Access: Demographic Factors Impacting Radial Artery Diameter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiology, Interventional
Keywords: specialty; RADIOGRAPHY, INTERVENTIONAL is available for the diagnostic and therapeutic procedures
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Terumo UK Ltd.
First posted: 2023-03-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients requiring Radial Artery Access at The Christie NHS Foundation Trust

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

* Patient demographics
* Diameter change post standard care preparation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radial Artery diameter
timeFrame: Before the procedure, during the procedure, and immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Pavan Najran, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.