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

NCT ID: NCT04023838

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2020-12-31

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.

Conditions

Radiation Exposure; Vascular Access Complication; Radial Artery Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Right conventional radial approach

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).

Group Type: PLACEBO_COMPARATOR

artery puncture and coronary angiography

Intervention Type: PROCEDURE

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).

Left distal radial approach

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).

Group Type: ACTIVE_COMPARATOR

artery puncture and coronary angiography

Intervention Type: PROCEDURE

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).

Interventions

artery puncture and coronary angiography

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chonnam National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Myung Ho Jeong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongcheol Kim, MD

Role: STUDY_DIRECTOR

Department of Cardiology, Chonnam National University Hospital

Central Contacts

Yongcheol Kim, MD

Role: CONTACT

Dr.YongcheolKim@gmail.com

+82-10-5808-4029

Other Identifiers

DOSE

Identifier Type: -

Identifier Source: org_study_id