Ignite Creation Date:
2024-05-06 @ 9:41 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03042845
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2017-02-01
Brief Title:
Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery the JUDGE Study
Sponsor:
University Hospital of Patras
Organization:
University Hospital of Patras
Study Overview
Official Title:
Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery the JUDGE Study
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JUDGE
Brief Summary:
The investigators aim to assess safety and efficiency of Tiger II 5Fr Terumo Interventional Systems Somerset New Jersey vs Judkins 5Fr 35L4R 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 35L4R 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 studys catheter next catheters selection will be at operators 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 05mgdl of serum creatinine within 48-72 hours of intravenous contrast administration Opacification grade 0poornon-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
0none and non-diagnostic study
1none but diagnostic study 2non-coaxial contact 3coaxial contact Catheter stability within the coronary ostium 0no catheters steady engagement of the ostium throughout the angiographic view
1catheters 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 005 group sample sizes of 316 and 316 will achieve 95 power to detect this difference
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 studys catheter next catheters selection will be at operators 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 05mgdl of serum creatinine within 48-72 hours of intravenous contrast administration Opacification grade 0poornon-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
0none and non-diagnostic study
1none but diagnostic study 2non-coaxial contact 3coaxial contact Catheter stability within the coronary ostium 0no catheters steady engagement of the ostium throughout the angiographic view
1catheters 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 005 group sample sizes of 316 and 316 will achieve 95 power to detect this difference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None