Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study (JUDGE)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Tiger cardiac catheter
Judkins 3.5L/4R cardiac catheters
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Indication for non-urgent coronary angiography
- Successful cannulation of right radial artery
- Availability of both Tiger and JL3.5/JR4 catheters
Exclusion Criteria
- Indication for urgent coronary angiography (ST-elevation myocardial infarction or non ST-elevation myocardial infarction with indication for coronary angiogram within 2 hours)
- Hemodynamic instability
- Non palpable right coronary artery
- Abnormal Allen test
- Prior coronary artery bypass grafting
- Chronic kidney disease or dialysis
Sites / Locations
- Patras University Hospital
- Second Department of Cardiology, Red Cross General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Judkins L3.5/R4 cardiac catheters
Tiger cardiac catheter
Arm Description
Outcomes
Primary Outcome Measures
Contrast volume
Contrast volume (in ml) between groups used for completion of coronary angiogram in intention to treat analysis analysis
Secondary Outcome Measures
Contrast volume
Contrast volume (in ml) between groups used for completion of coronary angiogram in per protocol analysis
Dose Area Product (DAP)
DAP (cGy*cm2) between groups in intention to treat and per protocol analysis
Fluoroscopy time
Fluoroscopy time (min) between groups in ITT and per protocol analysis
Contrast induced nephropathy (CIN)
CIN rate between groups in ITT and per protocol analysis
Catheter failure
Catheter failure rate between groups
Severe spasm
Severe spasm rate between groups
Coronary angiogram time
Duration of coronary angiogram between groups in ITT and per protocol analysis
Opacification grade
Opacification grade for LAD, LCX and RCA between study catheters
Contact to coronary ostium
Contact to left and right coronary ostium between study catheters
Stability within the coronary ostium
Catheter's steady engagement of the ostium throughout the angiographic view
Full Information
NCT ID
NCT03042845
First Posted
February 1, 2017
Last Updated
May 25, 2017
Sponsor
University Hospital of Patras
1. Study Identification
Unique Protocol Identification Number
NCT03042845
Brief Title
Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study
Acronym
JUDGE
Official Title
Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
May 25, 2017 (Actual)
Study Completion Date
May 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Patras
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo Interventional Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co) catheters, in coronary angiography via the right transradial route. This is a prospective, randomized, two-centre, study of parallel design. Consecutive patients with acute coronary syndrome (ACS), eligible for non-urgent coronary angiography, are randomized after successful cannulation of right radial artery and informed consent to either Tigger II or Judkins 3.5L/4R catheters.
Detailed Description
From the entrance of the first diagnostic catheter into the sheath and until the completion of the diagnostic coronary angiography will be the measurement of the endpoints of the study.
In case of failure to complete the coronary angiogram with the catheter study a crossover to the other catheter of the study will take place except in cases of severe spasm, where catheter choice will be at the discretion of the operator. In case of failure of the other study's catheter, next catheter's selection will be at operator's discretion. Patients included in the study, who do not process to adhoc PCI, will be monitored with baseline creatinine and creatinine value at day 2 or 3 after coronary angiography.
In all angiography films will be conducted offline analysis by two experienced operators for scoring opacification grade and coronary ostium contact with the catheters used.
DEFINITIONS Mild spasm Spasm causing well tolerated local pain Moderate spasm Spasm which causes severe pain but the handling of catheters remains satisfactory Severe spasm Spasm that leads to change diagnostic catheter or access site Duration of coronary angiogram Is defined as the time from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Radiation time Radiation time from the insertion of the first diagnostic coronary catheter in the right radial sheath to the exit of the last diagnostic catheter from the sheath Dose area product (DAP) DAP from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Contrast volume Contrast volume (ml) used from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Contrast induced nephropathy (CIN) Relative increase ≥25% from baseline or absolute increase ≥ 0.5mg/dl of serum creatinine within 48-72 hours of intravenous contrast administration Opacification grade 0=poor/non-diagnostic
moderate opacification only in systole or diastole
moderate opacification throughout cardiac cycle
complete opacification but not throughout cardiac cycle
complete opacification throughout cardiac cycle Catheter contact with coronary ostium
0=none and non-diagnostic study
1=none but diagnostic study 2=non-coaxial contact 3=coaxial contact Catheter stability within the coronary ostium 0=no catheter's steady engagement of the ostium throughout the angiographic view
1=catheter's steady engagement of the ostium throughout the angiographic view Catheter failure Completion of coronary angiogram after study catheter crossover with or without right radial access site crossover Based on pilot data and previously published data we hypothesized that Tiger catheter use will lead to an absolute decrease of at least 5 ml in contrast volume compared with Judkins catheters (48 and 53 ml for Tiger και Judkins catheters respectively, with estimated standard deviation of 17 for both). With a 2-sided alpha of 0.05, group sample sizes of 316 and 316 will achieve 95% power to detect this difference.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Judkins L3.5/R4 cardiac catheters
Arm Type
Active Comparator
Arm Title
Tiger cardiac catheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tiger cardiac catheter
Intervention Description
Tiger cardiac catheter
Intervention Type
Device
Intervention Name(s)
Judkins 3.5L/4R cardiac catheters
Intervention Description
Judkins 3.5L/4R cardiac catheters
Primary Outcome Measure Information:
Title
Contrast volume
Description
Contrast volume (in ml) between groups used for completion of coronary angiogram in intention to treat analysis analysis
Time Frame
End of coronary angiography
Secondary Outcome Measure Information:
Title
Contrast volume
Description
Contrast volume (in ml) between groups used for completion of coronary angiogram in per protocol analysis
Time Frame
End of coronary angiography
Title
Dose Area Product (DAP)
Description
DAP (cGy*cm2) between groups in intention to treat and per protocol analysis
Time Frame
End of coronary angiography
Title
Fluoroscopy time
Description
Fluoroscopy time (min) between groups in ITT and per protocol analysis
Time Frame
End of coronary angiography
Title
Contrast induced nephropathy (CIN)
Description
CIN rate between groups in ITT and per protocol analysis
Time Frame
End of coronary angiography
Title
Catheter failure
Description
Catheter failure rate between groups
Time Frame
End of coronary angiography
Title
Severe spasm
Description
Severe spasm rate between groups
Time Frame
End of coronary angiography
Title
Coronary angiogram time
Description
Duration of coronary angiogram between groups in ITT and per protocol analysis
Time Frame
End of coronary angiography
Title
Opacification grade
Description
Opacification grade for LAD, LCX and RCA between study catheters
Time Frame
End of coronary angiography
Title
Contact to coronary ostium
Description
Contact to left and right coronary ostium between study catheters
Time Frame
End of coronary angiography
Title
Stability within the coronary ostium
Description
Catheter's steady engagement of the ostium throughout the angiographic view
Time Frame
End of coronary angiography
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Indication for non-urgent coronary angiography
Successful cannulation of right radial artery
Availability of both Tiger and JL3.5/JR4 catheters
Exclusion Criteria
Indication for urgent coronary angiography (ST-elevation myocardial infarction or non ST-elevation myocardial infarction with indication for coronary angiogram within 2 hours)
Hemodynamic instability
Non palpable right coronary artery
Abnormal Allen test
Prior coronary artery bypass grafting
Chronic kidney disease or dialysis
Facility Information:
Facility Name
Patras University Hospital
City
Patras
State/Province
Achaia
ZIP/Postal Code
26500
Country
Greece
Facility Name
Second Department of Cardiology, Red Cross General Hospital
City
Athens
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study
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