Cardiac DiseaseQUEENNCT06179329
One-year Patency Comparison Between Radial Artery and No-touch Saphenous Vein Grafts in Women Undergoing Isolated CABG
A study testing Coronary artery bypass graft in people with Cardiac Disease and Surgery-Complications, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cardiac Disease, Surgery-Complications, Graft Failure
- What is being tested?
- Coronary artery bypass graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
São Paulo, São Paulo, 05403-900
Omar AV Mejia, MD, PhD, omar.mejia@incor.usp.br
Fabiane L Freitas, BsC, fabiane.freitas@fm.usp.br
About this study
Official title: No-Touch Saphenous Venous Harvesting TechniQue versUs Radial artEry in Coronary Artery Bypass Grafting in womEN: The QUEEN Multicenter Randomized Controlled 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.
- Conditions
- Cardiac Disease, Surgery-Complications, Graft Failure
- Being tested
- Coronary artery bypass graft
- Keywords
- Cardiovascular Surgery, Coronary Disease, Women, Graft patency
- Medical subject headings
- Heart Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass graftProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Radial - Anterolateral / Saphenous - RCA | Other | Radial artery graft for the anterolateral wall, and "no-touch" saphenous vein graft for the right coronary artery territory Receives: 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. Receives: Procedure: Coronary artery bypass graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Thirty days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Cardiologia, Hospital Unimed João Pessoa, Hospital do Coração Alagoano Prof. Adib Jatene, Hospital Hernan Henriquez Aravena, Hospital Norte Paranaense
- Responsible party
- Sponsor
- Investigators
- Omar AV Mejia, MD, PhD, Principal investigator, InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179329
- Sponsor's protocol ID
- 5723/23/125
- Acronym
- QUEEN
- Status last verified
- Nov 2025
- First submitted
- 6 Dec 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No-Touch Saphenous Venous Harvesting TechniQue versUs Radial artEry in Coronary Artery Bypass Grafting in womEN: The QUEEN Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06179329
- Acronym / sponsor ID
- QUEEN / 5723/23/125
- Conditions
- Cardiac Disease, Surgery-Complications, Graft Failure
- Keywords
- Cardiovascular Surgery, Coronary Disease, Women, Graft patency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Instituto Nacional de Cardiologia, Hospital Unimed João Pessoa, Hospital do Coração Alagoano Prof. Adib Jatene, Hospital Hernan Henriquez Aravena, Hospital Norte Paranaense
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial - Anterolateral / Saphenous - RCA | Other | Procedure: Coronary artery bypass graftRadial artery graft for the anterolateral wall, and "no-touch" saphenous vein graft for the right coronary artery territory |
| Radial - RCA / Saphenous - Anterolateral | Other | Procedure: Coronary artery bypass graftRadial artery graft for the territory of the right coronary artery and "no-touch" saphenous vein for the anterolateral wall. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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%.
Key exclusion criteria (14 listed)
- Preoperative conditions:
- Inability to use the saphenous and/or radial vein
- Conditions that may affect patient follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary artery bypass graftRandomization 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. | Procedure or surgery | Radial - Anterolateral / Saphenous - RCA, Radial - RCA / Saphenous - Anterolateral |
Primary outcome
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
1 secondary outcome
Evaluate in-hospital clinical outcomes 30 days after CABG
Time frame: Thirty days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar AV Mejia, MD, PhD principal investigator
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary artery bypass graft in people with Cardiac Disease and Surgery-Complications, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar A V Mejia, MD, PhD (+551126615014, omarvmejia@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One Follow-up with angiography (time frame: One year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.