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

Not Applicable

Completed

• Conditions: Vascular Access Complication; Coronary Artery Disease
• Interventions: Procedure: Coronary Angiography

• Registration Number: NCT03393052
• Lead Sponsor: University Hospital of Patras

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.

Study Timeline

• Study Start: 2017-01-20
• Study First Submitted: 2017-12-31
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-08
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-03
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age over 18 years
2. Written informed consent
3. Clinical indication for coronary angiography in a patient with prior history of CABG
4. Left radial artery has not been used as a graft during CABG

Exclusion Criteria

1. Age over 90 years
2. Patient's refusal to participate in the study
3. Hemodynamic instability of the patient
4. Failure to place a sheath at the randomization access site
5. Arteriovenous fistula at the left upper limb
6. Use of right internal mammary artery as a graft during CABG
7. Creatinine clearance <30 ml/min

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Radial access	Coronary Angiography	Left Radial approach for coronary angiography in patients with prior history of CABG surgery
Femoral access	Coronary Angiography	Femoral approach for coronary angiography in patients with prior history of CABG surgery

Primary Outcome Measures

Name	Time	Method
Net Procedure Time	24 hours	The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Patras; 🇬🇷 Patras, Achaia, Greece