Actively Recruiting
No-Touch Saphenous Venous Harvesting Technique Versus Radial Artery in Coronary Artery Bypass Grafting in Women: The QUEEN Multicenter Randomized Controlled Trial
Led by University of Sao Paulo General Hospital · Updated on 2025-12-12
150
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo General Hospital
Lead Sponsor
I
Instituto Nacional de Cardiologia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two types of grafts used in coronary artery bypass grafting (CABG) for women with heart disease involving three major arteries. The study aims to evaluate which graft—the radial artery or a "no-touch" saphenous vein graft—shows better long-term openness (patency) when used in the second most important coronary artery. This trial focuses specifically on women and addresses a current challenge in choosing the best graft for improving surgical outcomes. Participants will be randomly assigned to one of two groups: one group will receive a radial artery graft for the anterolateral wall and a "no-touch" saphenous vein graft for the right coronary artery area, while the other group will have the reverse arrangement. The randomization is done just before surgery to determine which grafting strategy will be used. This controlled procedure is designed to compare outcomes in a structured and unbiased way. Women aged 18 to 75 undergoing their first isolated CABG with specific heart artery conditions will be involved. Follow-up includes an angiography exam one year after surgery to assess graft patency, and clinical outcomes will also be evaluated 30 days after surgery. Safety and adherence are closely monitored. The total participation includes preoperative assessment, surgery, and scheduled follow-ups to track the success and any complications associated with the grafts.
CONDITIONS
Brief Title
One-year Patency Comparison Between Radial Artery and No-touch Saphenous Vein Grafts in Women Undergoing Isolated CABG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older and younger than 75 years
- Undergoing isolated and primary myocardial revascularization surgery
- Diagnosed with three-vessel coronary artery disease involving vessels suitable for surgery
- Left ventricular ejection fraction greater than 35%
- Target coronary vessels (left circumflex and right coronary artery territories) with diameter at least 1.5 mm and proximal obstructive lesions of at least 70%
You will not qualify if you...
- Lack of written informed consent
- Poorly controlled diabetes with glycated hemoglobin above 8 mg/dl
- Emergency or salvage surgery due to critical condition
- Renal failure with glomerular filtration rate below 30 mL/min
- Positive Allen test indicating inadequate blood flow for graft use
- Abnormal blood flow detected by Doppler exam in graft areas
- History of vasculitis or Raynaud's syndrome
- Presence of varicose veins or previous saphenous vein removal
- Advanced peripheral arterial disease
- Documented allergy to contrast agents used in imaging
- Inability to be followed up due to geographic inaccessibility
- Poor adherence to medical guidelines or prescribed medications
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery plus hospital stay
Participants undergo coronary artery bypass graft surgery using either the radial artery or the no-touch saphenous vein graft technique, followed by immediate post-operative care.
1 surgery visit and hospital monitoring
Duration - 30 days after surgery
Participants are monitored for clinical outcomes and recovery after surgery.
1 follow-up visit
Duration - One year after surgery
Participants have angiography to assess graft patency one year after surgery.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
São Paulo, São Paulo, Brazil, 05403-900
Actively Recruiting
Research Team
O
Omar A V Mejia, MD, PhD
L
Leonardo L Lacava, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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