Comparison of Left and Right Transradial Approach for CAG and PCI (COMPARE-Rad)

Comparison Between Left and Right Transradial Approach During Coronary Angiography and Percutaneous Coronary Intervention

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Stable Angina; ST-segment Elevation Myocardial Infarction; Unstable Angina; Non-ST Elevation Myocardial Infarction; Ischemic Heart Disease Without Angina
• Intervention / Treatment: Procedure: Radial approach

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 Type: Interventional
• Enrollment (Actual): 322
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon
    • Wonju, Gangwon, Korea, Republic of, 26426
      • Wonju Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Right radial approach; Right radial approach for coronary angiography and coronary intervention	Procedure: Radial approach; Approach site for coronary angiography and coronary intervention
Active Comparator: Left radial approach; Left radial approach for coronary angiography and coronary intervention	Procedure: Radial approach; Approach site for coronary angiography and coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Finishing coronary angiography/intervention without changing approach site	At the end of procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): September 7, 2017
• Study Completion (Actual): September 7, 2017

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Transradial access; Coronary artery disease; Learning curve; Access site
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; ST Elevation Myocardial Infarction; Angina Pectoris; Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction
• Other Study ID Numbers: CR316096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No