Clinical trial NCT03042845: Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study
Official title: Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 640
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

1. moderate opacification only in systole or diastole
2. moderate opacification throughout cardiac cycle
3. complete opacification but not throughout cardiac cycle
4. 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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Indication for non-urgent coronary angiography
3. Successful cannulation of right radial artery
4. Availability of both Tiger and JL3.5/JR4 catheters

Exclusion Criteria

1. Indication for urgent coronary angiography (ST-elevation myocardial infarction or non ST-elevation myocardial infarction with indication for coronary angiogram within 2 hours)
2. Hemodynamic instability
3. Non palpable right coronary artery
4. Abnormal Allen test
5. Prior coronary artery bypass grafting
6. Chronic kidney disease or dialysis

Primary outcomes:
measure: Contrast volume
timeFrame: End of coronary angiography
Secondary outcomes:
measure: Contrast volume
timeFrame: End of coronary angiography
measure: Dose Area Product (DAP)
timeFrame: End of coronary angiography
measure: Fluoroscopy time
timeFrame: End of coronary angiography
measure: Contrast induced nephropathy (CIN)
timeFrame: End of coronary angiography
measure: Catheter failure
timeFrame: End of coronary angiography
measure: Severe spasm
timeFrame: End of coronary angiography
measure: Coronary angiogram time
timeFrame: End of coronary angiography
measure: Opacification grade
timeFrame: End of coronary angiography
measure: Contact to coronary ostium
timeFrame: End of coronary angiography
measure: Stability within the coronary ostium
timeFrame: End of coronary angiography
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Patras University Hospital
state: Achaia
city: Athens
country: Greece
facility: Second Department of Cardiology, Red Cross General Hospital
Study officials:
References: