Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy (L-RECORD)

University Hospital of Patras

Status: Completed

Conditions: Coronary Artery Disease; Vascular Access Complication

Treatments: Procedure: Coronary Angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT03393052

5602

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Left Radial access

Active Comparator group

Description:

Left Radial approach for coronary angiography in patients with prior history of CABG surgery

Treatment:

Procedure: Coronary Angiography

Femoral access

Active Comparator group

Description:

Femoral approach for coronary angiography in patients with prior history of CABG surgery

Treatment:

Procedure: Coronary Angiography