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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-20

Study Completion Date

2018-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transradial Versus Transulnar Artery Approach for Coronary Interventions

NCT01364532

Arterial Access in Percutaneous Coronary Angiography or Intervention

UNKNOWN PHASE3

Patient Preference for Radial Versus Femoral Vascular Access

NCT02625493

Coronary Artery Disease

COMPLETED

Comparison of the Proximal Approach and Distal Approach of Axillary Vein Catheterization Under Ultrasound Guidance

NCT03395691

Central Venous Catheterization

COMPLETED NA

A Comparison of Left and Right Radial Approach for Percutaneous Coronary Procedures

NCT02034084

Transradial Approach, Coronary Angiography, Percutaneous Coronary

COMPLETED NA

Ultrasound-guided Axillary Versus Conventional Cephalic Venous Access for Implantation of Cardiac Devices

NCT04958369

Pacemaker Implantable Cardioverter-defibrillator

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Vascular Access Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Left Radial access

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

Group Type ACTIVE_COMPARATOR

Coronary Angiography

Intervention Type PROCEDURE

Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery

Femoral access

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

Group Type ACTIVE_COMPARATOR

Coronary Angiography

Intervention Type PROCEDURE

Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coronary Angiography

Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No