NCT06179329 One-year Patency Comparison Between Radial Artery and No-touch Saphenous Vein Grafts in Women Undergoing Isolated CABG
| NCT ID | NCT06179329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Cardiac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-01-01 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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: 1. 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. 2. 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 3. 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.
Contact & Investigator
Omar AV Mejia, MD, PhD
PRINCIPAL INVESTIGATOR
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
Frequently Asked Questions
Who can join the NCT06179329 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Cardiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06179329 currently recruiting?
Yes, NCT06179329 is actively recruiting participants. Contact the research team at omarvmejia@incor.usp.br for enrollment information.
Where is the NCT06179329 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06179329 clinical trial?
NCT06179329 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Omar AV Mejia, MD, PhD at InCor - Instituto do Coração do Hospital das Clínicas da FMUSP. The trial plans to enroll 150 participants.