Comparison of Left and Right Transradial Approach for CAG and PCI

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Non-ST Elevation Myocardial Infarction; ST-segment Elevation Myocardial Infarction; Stable Angina; Ischemic Heart Disease Without Angina; Unstable Angina
• Interventions: Procedure: Radial approach

• Registration Number: NCT03389503
• Lead Sponsor: Wonju Severance Christian Hospital

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).

Study Timeline

• Study Start: 2017-03-08
• Primary Completion: 2017-09-07
• Study Completion: 2017-09-07
• Status Verified: 2017-12
• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2017-12-27
• Last Update Submitted: 2017-12-27
• Study First Posted: 2018-01-03
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Right radial approach	Radial approach	Right radial approach for coronary angiography and coronary intervention
Left radial approach	Radial approach	Left radial approach for coronary angiography and coronary intervention

Primary Outcome Measures

Name	Time	Method
Procedural success	At the end of procedure	Finishing coronary angiography/intervention without changing approach site

Secondary Outcome Measures

Name	Time	Method
Puncture time	At the end of procedure	Duration from the start of local anesthesia infiltration to the insertion of sheath
Contrast amount during coronary angiography	At the end of procedure	Amount of contrast agent used during coronary angiography
Fluoroscopic time during coronary intervention	At the end of procedure	Fluoroscopic time during coronary intervention
Coronary angiography time	At the end of procedure	Duration from the insertion of sheath to the end of coronary angiography
Puncture + Coronary angiography time	At the end of procedure	Sum of puncture time and coronary angiography time
Contrast amount during coronary intervention	At the end of procedure	Amount of contrast agent used during coronary intervention
Coronary intervention time	At the end of procedure	Duration from the end of coronary angiography to the end of coronary intervention
Fluoroscopic dose, dose area product during coronary angiography	At the end of procedure	Dose area product during coronary angiography
Fluoroscopic dose, dose area product during coronary intervention	At the end of procedure	Dose area product during coronary intervention
Fluoroscopic time during coronary angiography	At the end of procedure	Fluoroscopic time during coronary angiography

Trial Locations

Locations (1)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon, Korea, Republic of