Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- University Hospital of Patras
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Net Procedure Time
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Tsigkas Grigorios
Interventional Cardiologist
University Hospital of Patras
Eligibility Criteria
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
Outcomes
Primary Outcomes
Net Procedure Time
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
Secondary Outcomes
- Major Cardiovascular Events(24 hours)
- Total Procedure Time(24 hours)
- Fluoroscopy Time(24 hours)
- Dose Area Product(24 hours)
- Contrast Volume(24 hours)
- Vascular Complications(24 hours)
- Crossover access site(24 hours)