Back to resultsComparison of Left and Right Transradial Approach for CAG and PCI (COMPARE-Rad)
Primary Purpose
Coronary Artery Disease, Stable Angina, Unstable Angina
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radial approach
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease focused on measuring Access site, Transradial access, Coronary artery disease, Learning curve
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)
Sites / Locations
- Wonju Severance Christian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Right radial approach
Left radial approach
Arm Description
Right radial approach for coronary angiography and coronary intervention
Left radial approach for coronary angiography and coronary intervention
Outcomes
Primary Outcome Measures
Procedural success
Finishing coronary angiography/intervention without changing approach site
Secondary Outcome Measures
Puncture time
Duration from the start of local anesthesia infiltration to the insertion of sheath
Coronary angiography time
Duration from the insertion of sheath to the end of coronary angiography
Puncture + Coronary angiography time
Sum of puncture time and coronary angiography time
Coronary intervention time
Duration from the end of coronary angiography to the end of coronary intervention
Contrast amount during coronary angiography
Amount of contrast agent used during coronary angiography
Contrast amount during coronary intervention
Amount of contrast agent used during coronary intervention
Fluoroscopic dose, dose area product during coronary angiography
Dose area product during coronary angiography
Fluoroscopic dose, dose area product during coronary intervention
Dose area product during coronary intervention
Fluoroscopic time during coronary angiography
Fluoroscopic time during coronary angiography
Fluoroscopic time during coronary intervention
Fluoroscopic time during coronary intervention
Full Information
NCT ID
NCT03389503
First Posted
December 27, 2017
Last Updated
December 27, 2017
Sponsor
Wonju Severance Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03389503
Brief Title
Comparison of Left and Right Transradial Approach for CAG and PCI
Acronym
COMPARE-Rad
Official Title
Comparison Between Left and Right Transradial Approach During Coronary Angiography and Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
September 7, 2017 (Actual)
Study Completion Date
September 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonju Severance Christian Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
1~3 months: Right radial approach 4~6 months: Left radial approach
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
322 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right radial approach
Arm Type
Active Comparator
Arm Description
Right radial approach for coronary angiography and coronary intervention
Arm Title
Left radial approach
Arm Type
Active Comparator
Arm Description
Left radial approach for coronary angiography and coronary intervention
Intervention Type
Procedure
Intervention Name(s)
Radial approach
Intervention Description
Approach site for coronary angiography and coronary intervention
Primary Outcome Measure Information:
Title
Procedural success
Description
Finishing coronary angiography/intervention without changing approach site
Time Frame
At the end of procedure
Secondary Outcome Measure Information:
Title
Puncture time
Description
Duration from the start of local anesthesia infiltration to the insertion of sheath
Time Frame
At the end of procedure
Title
Coronary angiography time
Description
Duration from the insertion of sheath to the end of coronary angiography
Time Frame
At the end of procedure
Title
Puncture + Coronary angiography time
Description
Sum of puncture time and coronary angiography time
Time Frame
At the end of procedure
Title
Coronary intervention time
Description
Duration from the end of coronary angiography to the end of coronary intervention
Time Frame
At the end of procedure
Title
Contrast amount during coronary angiography
Description
Amount of contrast agent used during coronary angiography
Time Frame
At the end of procedure
Title
Contrast amount during coronary intervention
Description
Amount of contrast agent used during coronary intervention
Time Frame
At the end of procedure
Title
Fluoroscopic dose, dose area product during coronary angiography
Description
Dose area product during coronary angiography
Time Frame
At the end of procedure
Title
Fluoroscopic dose, dose area product during coronary intervention
Description
Dose area product during coronary intervention
Time Frame
At the end of procedure
Title
Fluoroscopic time during coronary angiography
Description
Fluoroscopic time during coronary angiography
Time Frame
At the end of procedure
Title
Fluoroscopic time during coronary intervention
Description
Fluoroscopic time during coronary intervention
Time Frame
At the end of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Gangwon
ZIP/Postal Code
26426
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Left and Right Transradial Approach for CAG and PCI
We'll reach out to this number within 24 hrs