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

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Dec 18, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating which type of graft works better for women undergoing heart surgery called coronary artery bypass grafting (CABG). Specifically, it compares two options: a graft from the radial artery in the arm and a "no-touch" technique using the saphenous vein from the leg. The goal is to see which graft stays open longer, which is important for the long-term success of the surgery.

To participate in the study, women aged 18 to 70 who are having surgery to improve blood flow to their heart may be eligible. They need to have three blocked coronary arteries and certain conditions that allow for the use of these grafts. If chosen for the trial, participants can expect to be monitored after their surgery to evaluate the performance of their graft. It’s important to note that this study is not yet recruiting participants, so there will be more information available in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women aged 18 years or older and younger than 70 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 \>7 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.