Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04023838
Acronym
DOSE
Enrollment
100
Registered
2019-07-18
Start date
2019-08-31
Completion date
2020-12-31
Last updated
2019-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radial Artery Injury, Radiation Exposure, Vascular Access Complication

Keywords

Radiation, Snuffbox approach, Radial approach, Vascular access

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.

Interventions

PROCEDUREartery 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).

Sponsors

Chonnam National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Patients will be randomized either conventional right radial approach or left distal radial approach.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Radiation dose of the operator (µSv)Through procedure completion, up to 6 hoursRadiation 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

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

Contacts

Primary ContactYongcheol Kim, MD
Dr.YongcheolKim@gmail.com+82-10-5808-4029

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026