Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach

Not Applicable

• Conditions: Vascular Access Complication; Radiation Exposure; Radial Artery Injury
• Interventions: Procedure: artery puncture and coronary angiography

• Registration Number: NCT04023838
• Lead Sponsor: Chonnam National University Hospital

Brief Summary

Randomized comparison of radiation exposure in coronary angiography between right conventional and left distal radial artery approach

Detailed Description

The left snuffbox approach is expected to be easier to perform because of less severe tortuosity of the clavicle artery. However, clinical validation of the snuffbox approach was not completed compared with the conventional radial approach. Especially, there is no clinical data on the comparison of the radiation dose in both approaches. To date, there have been some studies on the radiation dose between the left and right radial artery and femoral artery puncture site, but no studies have been conducted on the left snuffbox approach.

The purpose of this study was to compare the radiation doses of the two interventional radiologists by randomly assigning coronary angiography to the left snuffbox approach and right conventional radial approach.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-17
• Last Update Submitted: 2019-07-17
• Study First Posted: 2019-07-18
• Last Update Posted: 2019-07-18
• Study Start: 2019-08
• Primary Completion: 2019-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients who are a palpable right radial artery and left distal radial artery
• The decision to participate voluntarily in this study and the written consent of the patient

Exclusion Criteria

• Patients who are not palpable right radial artery and left distal radial artery
• Patients who have arteriovenous fistula
• Patients presenting with acute myocardial infarction
• Patients who need to perform coronary angiography via femoral approach, such as shock state
• Patients who have atrioventricular block on the electrocardiogram
• Patients who have a plan to perform Ergonovine provocation test
• Patients who need percutaneous coronary intervention
• Patients who are not appropriate for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left distal radial approach	artery puncture and coronary angiography	After local anesthesia on left anatomical snuffbox area with lidocaine hydrochloride using a 26 gauge needle, the puncture is performed using a 20 gauge needle with the through-and-through puncture technique or a 21 gauge open needle with anterior wall puncture technique. After the successful puncture, 0.025-inch straight wire or 0.018-inch hair wire are inserted, followed by insertion of the 5Fr. radial sheath (Prelude® Radial; Merit medical, UT, USA or Radifocus® Introducer II or Glidesheath Slender®; Terumo Corporation, Tokyo, Japan).
Right conventional radial approach	artery puncture and coronary angiography	After local anesthesia on right wrist area with lidocaine hydrochloride using a 26 gauge needle, the puncture is performed using a 20 gauge needle with the through-and-through puncture technique or a 21 gauge open needle with anterior wall puncture technique. After the successful puncture, 0.025-inch straight wire or 0.018-inch hair wire are inserted, followed by insertion of the 5Fr. radial sheath (Prelude® Radial; Merit medical, UT, USA or Radifocus® Introducer II or Glidesheath Slender®; Terumo Corporation, Tokyo, Japan).

Primary Outcome Measures

Name	Time	Method
Radiation dose of the operator (µSv)	Through procedure completion, up to 6 hours	Radiation dose (µSv) of the operator's head, hand, and body will be compared between right conventional radial artery approach and left snuffbox approach group.

Secondary Outcome Measures

Name	Time	Method
Fluoroscopy time for coronary angiography (second)	Through procedure completion, up to 6 hours	Fluoroscopy time (second) will be compared between two groups during coronary angiography.
Hemostasis duration (minute)	During hospitalization, up to 1 month	Hemostasis (minute) is obtained by compressive bandage with ez ClotRadial® (SOYEON medical Co., Ltd., Wonju, Korea)
Dose-area product (mGy*cm2)	Through procedure completion, up to 6 hours	Dose-area product (DAP) (mGy\*cm2) will be compared between two groups during coronary angiography.
Success rate of radial puncture (%)	Through procedure completion, up to 6 hours	Successful introduction of sheath (%)
Cannulation time (second)	Through procedure completion, up to 6 hours	Time from local anesthesia to sheath cannulation (second)
Puncture site complication after hemostasis	During hospitalization, up to 1 month	Evaluation of puncture-site bleeding complication using EASY criteria