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

Chonnam National University

Status: Unknown

Conditions: Vascular Access Complication; Radial Artery Injury; Radiation Exposure

Treatments: Procedure: artery puncture and coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT04023838

DOSE

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Right conventional radial approach

Placebo Comparator group

Description:

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).

Treatment:

Procedure: artery puncture and coronary angiography

Left distal radial approach

Active Comparator group

Description:

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).

Treatment:

Procedure: artery puncture and coronary angiography