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

NCT06179329 | Recruiting DMC

• 1 other identifier: 5723/23/125
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Disease; Surgery-Complications; Graft Failure

Keywords

Cardiovascular Surgery; Coronary Disease; Women; Graft patency

Outcome Measures

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

  One year after surgery

Secondary Outcomes (1)

• Evaluate in-hospital clinical outcomes 30 days after CABG

  Thirty days after surgery

Study Arms (2)

Radial - Anterolateral / Saphenous - RCA

OTHER

Radial artery graft for the anterolateral wall, and "no-touch" saphenous vein graft for the right coronary artery territory

Procedure: Coronary artery bypass graft

Radial - RCA / Saphenous - Anterolateral

OTHER

Radial artery graft for the territory of the right coronary artery and "no-touch" saphenous vein for the anterolateral wall.

Procedure: Coronary artery bypass graft

Interventions

Coronary artery bypass graft PROCEDURE

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.

Radial - Anterolateral / Saphenous - RCA; Radial - RCA / Saphenous - Anterolateral

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years or older and younger than 75 years, undergoing isolated and primary myocardial revascularization surgery, with triarterial coronary artery disease (three vessels involved) in vessels subject to surgical revascularization and left ventricular ejection fraction greater than 35%. The target coronary vessels of the study will be those in the territory of the left circumflex artery and the right coronary artery, which must have at least 1.5 mm in diameter, and with proximal obstructive lesions of at least 70%.

You may not qualify if:

• Preoperative conditions:
• 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.
• Inability to use the saphenous and/or radial vein
• Positive Allen test using a pulse oximeter
• Presence of abnormal flow detected by means of a Doppler exam in one of the grafts to be used.
• History of vasculitis or Raynaud's syndrome, varicose veins, or history of previous saphenous vein removal
• Conditions that may affect patient follow-up
• Presence of advanced peripheral arterial disease
• Known contrast allergy: Presence of a documented allergy to the contrast agent used in radiological procedures.
• Impossibility of tracking due to geographic inaccessibility.
• Patients with lack of adherence to guidelines and/or prescribed medications.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• 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

Study Sites (1)

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Coronary Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Omar AV Mejia, MD, PhD

  InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar A V Mejia, MD, PhD

CONTACT

+551126615014; omarvmejia@incor.usp.br

Leonardo L Lacava, MD

CONTACT

+55 49 33224453; lacavalopes@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 21, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)