University Hospital of Patras
Pátrai, Achaia, 26504, Greece
NCT Number: NCT03393052
This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Pátrai, Achaia, 26504, Greece
Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or femoral access. Based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (Net procedure time). Secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery
Time frame: 24 hours
The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
Time frame: 24 hours
The time (min) from local anesthesia at the access site until the completion of the diagnostic coronary angiography
Time frame: 24 hours
Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
Time frame: 24 hours
Radiation DAP (mGy*cm2) during the diagnostic coronary angiography
Time frame: 24 hours
Contrast volume (ml) used during the diagnostic coronary angiography
Time frame: 24 hours
Need for crossover access site, other than this of randomization
Time frame: 24 hours
Death, stroke, acute myocardial infarction
Time frame: 24 hours
Vascular access complications
University Hospital of Patras
Other
Acronym: L-RECORD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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