Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06179329

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403-900, Brazil

Location status: Recruiting

Location contact

Diego PG Andrade, MD

PRINCIPAL_INVESTIGATOR

Fabiane L Freitas, BsC

CONTACT

[email protected]

Fabiane L Freitas, BsC

PRINCIPAL_INVESTIGATOR

Fabiano G Jucá, MD

PRINCIPAL_INVESTIGATOR

Leonardo L Lacava, MD

PRINCIPAL_INVESTIGATOR

Maurílio O Deininger, MD, PhD

PRINCIPAL_INVESTIGATOR

Omar AV Mejia, MD, PhD

CONTACT

[email protected]

Omar AV Mejia, MD, PhD

PRINCIPAL_INVESTIGATOR

Rodrigo C Segalote, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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%.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. One Follow-up with angiography

    Time frame: One year after surgery

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

Secondary outcomes

  1. Evaluate in-hospital clinical outcomes 30 days after CABG

    Time frame: Thirty days after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leonardo L Lacava, MD

CONTACT

[email protected]

+55 49 33224453

Omar A V Mejia, MD, PhD

CONTACT

[email protected]

+551126615014

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Hospital Hernan Henriquez Aravena
  • Hospital Norte Paranaense
  • Hospital Unimed João Pessoa
  • Hospital do Coração Alagoano Prof. Adib Jatene
  • Instituto Nacional de Cardiologia

Registry information

Official study title

No-Touch Saphenous Venous Harvesting TechniQue versUs Radial artEry in Coronary Artery Bypass Grafting in womEN: The QUEEN Multicenter Randomized Controlled Trial

Acronym: QUEEN

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Dec 21, 2023
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.