Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study
JUDGE
1 other identifier
interventional
640
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Oct 2016
Shorter than P25 for not_applicable coronary-artery-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2017
CompletedMay 30, 2017
May 1, 2017
8 months
February 1, 2017
May 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Contrast volume
Contrast volume (in ml) between groups used for completion of coronary angiogram in intention to treat analysis analysis
End of coronary angiography
Secondary Outcomes (10)
Contrast volume
End of coronary angiography
Dose Area Product (DAP)
End of coronary angiography
Fluoroscopy time
End of coronary angiography
Contrast induced nephropathy (CIN)
End of coronary angiography
Catheter failure
End of coronary angiography
- +5 more secondary outcomes
Study Arms (2)
Judkins L3.5/R4 cardiac catheters
ACTIVE COMPARATORTiger cardiac catheter
EXPERIMENTALInterventions
Judkins 3.5L/4R cardiac catheters
Eligibility Criteria
You may qualify if:
- Written informed consent
- Indication for non-urgent coronary angiography
- Successful cannulation of right radial artery
- Availability of both Tiger and JL3.5/JR4 catheters
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Patras University Hospital
Pátrai, Achaia, 26500, Greece
Second Department of Cardiology, Red Cross General Hospital
Athens, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiologist
Study Record Dates
First Submitted
February 1, 2017
First Posted
February 3, 2017
Study Start
October 1, 2016
Primary Completion
May 25, 2017
Study Completion
May 25, 2017
Last Updated
May 30, 2017
Record last verified: 2017-05