One-year Patency Comparison Between Radial Artery and No-touch Saphenous Vein Grafts in Women Undergoing Isolated CABG

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorUniversity of Sao Paulo General Hospital

About this trial

The use of a graft from the left internal thoracic artery to the left anterior descending artery has become the gold standard for the indication of coronary artery bypass grafting. However, choosing a graft for the second-best coronary artery, focusing on long-term patency, is still a challenge. The saphenous vein using the "no-touch" technique is an alternative to a radial artery graft, but there is little evidence, especially in women. This randomized clinical study aims to compare the patency of these grafts in the second-best coronary artery in women undergoing coronary artery bypass grafting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Lack of the patient's written informed consent.

Presence of poorly controlled diabetes, with a glycated hemoglobin value >8 mg/dl.

Emergency or salvage surgery, where the intervention needs to be performed quickly due to the critical clinical condition of the patient.

Renal failure with glomerular filtration rate (creatinine clearance) <30 mL/min.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coronary artery bypass graft

    Procedure/Surgery

    Randomization will be performed for stratification according to the target coronary arteries and the randomly determined block size from 4 to 6. The randomization result will be delivered in a sealed envelope in the operating room (before the time out) for one of the two drawn strategies.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Radial - Anterolateral / Saphenous - RCAOther 1 intervention
Group B: Radial - RCA / Saphenous - AnterolateralOther 1 intervention

Trial outcomes

Primary outcomes

1

One Follow-up with angiography

The primary endpoint will be the proportion of saphenous vein and radial artery grafts that were completely occluded on follow-up angiography

Time frame
One year after surgery

Secondary outcomes

1

Evaluate in-hospital clinical outcomes 30 days after CABG

Death from any cause, perioperative myocardial infarction (occurring between 0 and 30 days), late myocardial infarction (occurring between 31 days and 1 year), reoperation of surgical revascularization and/or coronary angioplasty. Hand claudication and thenar paresthesia, complications potentially related to radial artery extraction, will be reported according to the specific diagnoses and confirmed with a consulting neurologist. As all patients will receive a radial artery graft, clinical events will be reported for the entire study population.

Time frame
Thirty days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Instituto Nacional de Cardiologia

Collaborator

Hospital Unimed João Pessoa

Collaborator

Hospital do Coração Alagoano Prof. Adib Jatene

Collaborator

Hospital Hernan Henriquez Aravena

Collaborator

Hospital Norte Paranaense

Collaborator