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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03393052
Study type Interventional
Source University Hospital of Patras
Contact
Status Completed
Phase N/A
Start date January 20, 2017
Completion date May 15, 2018

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