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QUEENNo-Touch Saphenous Vein vs. Radial Artery in Women's Coronary Bypass

Study Aim

This study aims to compare the effectiveness of no-touch saphenous vein grafts with radial artery grafts in women undergoing coronary bypass surgery by observing graft occlusion rates.

What is being tested

Coronary artery bypass graft

Procedure

Who is being recruted

Cardiovascular Diseases+2

+ Coronary Disease

+ Heart Diseases

From 18 to 75 Years

+4 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: January 2024

See protocol details

Summary

Principal SponsorUniversity of Sao Paulo General Hospital

Study ContactOmar A V Mejia, MD, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2024

Actual date on which the first participant was enrolled.

This study explores two different methods for obtaining blood vessels for heart surgery, specifically in women requiring coronary artery bypass grafting. The focus is on comparing the long-term effectiveness of using a saphenous vein with a special technique called "no-touch" against using a radial artery. The aim is to determine which method provides a better and longer-lasting graft for the second-best coronary artery after the main artery has been treated. This is important because it could improve surgical results and long-term heart health for women undergoing this type of surgery. Participants in this study will undergo coronary artery bypass grafting, where surgeons will use either the no-touch technique on the saphenous vein or the radial artery for the grafting process. The effectiveness of each method will be evaluated by checking how well these grafts remain open and functional over time. This is measured through follow-up assessments after the surgery to ensure the selected technique provides the best possible outcome for the patients. The study aims to provide more evidence to help doctors decide the best approach for women needing this procedure.

Official TitleNo-Touch Saphenous Venous Harvesting TechniQue versUs Radial artEry in Coronary Artery Bypass Grafting in womEN: The QUEEN Multicenter Randomized Controlled Trial

NCT06179329

Principal SponsorUniversity of Sao Paulo General Hospital

Study ContactOmar A V Mejia, MD, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial Ischemia

Criteria

1 inclusion criteria required to participate

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%.

3 exclusion criteria prevent from participating

Conditions that may affect patient follow-up: 1. Presence of advanced peripheral arterial disease 2. Known contrast allergy: Presence of a documented allergy to the contrast agent used in radiological procedures. 3. Impossibility of tracking due to geographic inaccessibility. 4. Patients with lack of adherence to guidelines and/or prescribed medications.

Inability to use the saphenous and/or radial vein: 1. Positive Allen test using a pulse oximeter 2. Presence of abnormal flow detected by means of a Doppler exam in one of the grafts to be used. 3. History of vasculitis or Raynaud's syndrome, varicose veins, or history of previous saphenous vein removal

Preoperative conditions: 1. Lack of the patient's written informed consent. 2. Presence of poorly controlled diabetes, with a glycated hemoglobin value \>8 mg/dl. 3. Emergency or salvage surgery, where the intervention needs to be performed quickly due to the critical clinical condition of the patient. 4. Renal failure with glomerular filtration rate (creatinine clearance) \<30 mL/min.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

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

São Paulo, BrazilOpen Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo in Google Maps

Recruiting

One Study Center