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NCT03389503 Clinical Trial

Comparison of Left and Right Transradial Approach for CAG and PCI

Coronary Artery Disease Clinical Trial

— COMPARE-Rad  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03389503
Other study ID # CR316096
Secondary ID
Status Completed
Phase N/A
First received December 27, 2017
Last updated December 27, 2017
Start date March 8, 2017
Est. completion date September 7, 2017

Study information
Verified date December 2017
Source Wonju Severance Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 322
Est. completion date September 7, 2017
Est. primary completion date September 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Radial approach
Approach site for coronary angiography and coronary intervention

Locations
Country Name City State
Korea, Republic of Wonju Severance Christian Hospital Wonju Gangwon

Sponsors (1)
Lead Sponsor Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Procedural success Finishing coronary angiography/intervention without changing approach site At the end of procedure
Secondary Puncture time Duration from the start of local anesthesia infiltration to the insertion of sheath At the end of procedure
Secondary Coronary angiography time Duration from the insertion of sheath to the end of coronary angiography At the end of procedure
Secondary Puncture + Coronary angiography time Sum of puncture time and coronary angiography time At the end of procedure
Secondary Coronary intervention time Duration from the end of coronary angiography to the end of coronary intervention At the end of procedure
Secondary Contrast amount during coronary angiography Amount of contrast agent used during coronary angiography At the end of procedure
Secondary Contrast amount during coronary intervention Amount of contrast agent used during coronary intervention At the end of procedure
Secondary Fluoroscopic dose, dose area product during coronary angiography Dose area product during coronary angiography At the end of procedure
Secondary Fluoroscopic dose, dose area product during coronary intervention Dose area product during coronary intervention At the end of procedure
Secondary Fluoroscopic time during coronary angiography Fluoroscopic time during coronary angiography At the end of procedure
Secondary Fluoroscopic time during coronary intervention Fluoroscopic time during coronary intervention At the end of procedure
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