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

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

Detailed Description
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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.

Official Title
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Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach: The DOSE Trial

Conditions
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Radiation Exposure, Vascular Access Complication, Radial Artery Injury

Intervention / Treatment
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* Procedure: artery puncture and coronary angiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized either conventional right radial approach or left distal radial approach.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Right conventional radial approach<br>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). | Procedure: artery puncture and coronary angiography<br>* We will perform coronary angiography through a Judkins 5 French diagnostic catheter and will take a basic view. At the end of the examination, the radial sheath is removed and the right conventional radial approach is performed for about 4 hours and the left snuffbox approach for about 2 hours using the compressive bandage method. The hemostatic device will use ez ClotRadial® (SOYEON medical Co., Ltd., Wonju, Korea).<br>|
| Active Comparator: Left distal radial approach<br>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). | Procedure: artery puncture and coronary angiography<br>* We will perform coronary angiography through a Judkins 5 French diagnostic catheter and will take a basic view. At the end of the examination, the radial sheath is removed and the right conventional radial approach is performed for about 4 hours and the left snuffbox approach for about 2 hours using the compressive bandage method. The hemostatic device will use ez ClotRadial® (SOYEON medical Co., Ltd., Wonju, Korea).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose of the operator (µSv) | 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. | Through procedure completion, up to 6 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation, Snuffbox approach, Radial approach, Vascular access