NCT06378775尚未招募不适用
Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery: a Pilot Trial
Cardiology Research UBC0 个研究点目标入组 80 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Post-operative Length of Stay
研究概览
简要总结
The study objective is to compare standard CABG to a hybrid revascularization strategy (RA-MIDCAB + PCI) in patients who have multi-vessel CAD and an indication for surgery, but who have a slightly higher risk of post-operative complications.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multi-vessel CAD with an indication for revascularization,
- •Presence of at least 1 risk factor for increased risk of post-operative death or major complication,
- •Any patient Age > 80, OR
- •Any patient with eGFR (Glomerular Filtration Rate) < 50, OR
- •Any patient with LVEF < 40%, OR
- •Any patient deemed to be "frail" by consulting surgeon. OR
- •Patients > 75 years of age with at least one of the following:
- •Ejection fraction < 50%
- •History of prior CVA (Cerebral Vascular Accident)
- •Coronary artery anatomy appropriate for a robotically-assisted MIDCAB or regular CABG, vessels other than the left anterior descending with lesions amenable to either CABG or PCI.
排除标准
- •Significant left main coronary artery disease,
- •Ejection fraction < 30%,
- •Patients with GFR < 30,
- •Patients unable to take dual anti-platelet agents due to high bleeding risk,
- •Patients requiring emergent surgery, including patients with hemodynamic instability,
- •Patients with anatomy not suitable for a robotically-assisted approach (by CT chest).
结局指标
主要结局
Post-operative Length of Stay
时间窗: From end of surgery (Skin time) to hospital discharge time, assessed up to 30 days
Number of days from end of surgery to hospital discharge
次要结局
- Conversion to sternotomy / CABG(From beginning of surgery time to end of surgery time (skin to skin))
研究者
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