Clinical trial NCT03389503: Comparison of Left and Right Transradial Approach for CAG and PCI
Official title: Comparison Between Left and Right Transradial Approach During Coronary Angiography and Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Stable Angina
Unstable Angina
Non-ST Elevation Myocardial Infarction
ST-segment Elevation Myocardial Infarction
Ischemic Heart Disease Without Angina
Keywords: Access site
Transradial access
Coronary artery disease
Learning curve
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 1\~3 months: Right radial approach 4\~6 months: Left radial approach
Primary purpose: OTHER

Brief summary: This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.

Detailed description: The three operators who are proficient in the left radial approach for coronary angiography and coronary intervention will be assigned to the right radial approach for 3 months (phase 1). After then, these three operators will switch approach site to the left radial for another 3 months (phase 2).

Procedural success, time of the procedure, use of contrast agent, and fluoroscopic data will be compared between right radial approach (phase 1) group and left radial approach (phase 2).

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing coronary angiography via radial approach
* Subjects undergoing coronary intervention via radial approach
* Subjects give written informed consent

Exclusion Criteria:

* Subjects undergoing procedure(s) other than coronary angiography or intervention
* Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)

Primary outcomes:
measure: Procedural success
timeFrame: At the end of procedure
Secondary outcomes:
measure: Puncture time
timeFrame: At the end of procedure
measure: Coronary angiography time
timeFrame: At the end of procedure
measure: Puncture + Coronary angiography time
timeFrame: At the end of procedure
measure: Coronary intervention time
timeFrame: At the end of procedure
measure: Contrast amount during coronary angiography
timeFrame: At the end of procedure
measure: Contrast amount during coronary intervention
timeFrame: At the end of procedure
measure: Fluoroscopic dose, dose area product during coronary angiography
timeFrame: At the end of procedure
measure: Fluoroscopic dose, dose area product during coronary intervention
timeFrame: At the end of procedure
measure: Fluoroscopic time during coronary angiography
timeFrame: At the end of procedure
measure: Fluoroscopic time during coronary intervention
timeFrame: At the end of procedure
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon
Study officials:
References: