Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy

Conditions
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Coronary Artery Disease, Vascular Access Complication

Intervention / Treatment
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* Procedure: Coronary Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Written informed consent Clinical indication for coronary angiography in a patient with prior history of CABG Left radial artery has not been used as a graft during CABG Exclusion Criteria: Age over 90 years Patient's refusal to participate in the study Hemodynamic instability of the patient Failure to place a sheath at the randomization access site Arteriovenous fistula at the left upper limb Use of right internal mammary artery as a graft during CABG Creatinine clearance <30 ml/min

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Left Radial access<br>Left Radial approach for coronary angiography in patients with prior history of CABG surgery | Procedure: Coronary Angiography<br>* Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery<br>|
| Active Comparator: Femoral access<br>Femoral approach for coronary angiography in patients with prior history of CABG surgery | Procedure: Coronary Angiography<br>* Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Procedure Time | The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Procedure Time | The time (min) from local anesthesia at the access site until the completion of the diagnostic coronary angiography | 24 hours | 
| Fluoroscopy Time | Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic coronary angiography | 24 hours | 
| Dose Area Product | Radiation DAP (mGy*cm2) during the diagnostic coronary angiography | 24 hours | 
| Contrast Volume | Contrast volume (ml) used during the diagnostic coronary angiography | 24 hours | 
| Crossover access site | Need for crossover access site, other than this of randomization | 24 hours | 
| Major Cardiovascular Events | Death, stroke, acute myocardial infarction | 24 hours | 
| Vascular Complications | Vascular access complications | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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L-RECORD, Radial, Femoral, CABG, coronary artery bypass graft