No-Touch Saphenous Venous Harvesting TechniQue versUs Radial artEry in Coronary Artery Bypass Grafting in womEN: The QUEEN Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- One Follow-up with angiography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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.
结局指标
主要结局
One Follow-up with angiography
时间窗: 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
次要结局
- Evaluate in-hospital clinical outcomes 30 days after CABG(Thirty days after surgery)