ACTRN12613000707763撤回未知
A Study to Evaluate the short term clinical outcomes of GALA (Trademark) Vascular Conduit Preservation Solution in Patients Undergoing Coronary Artery Bypass Graft Surgery.
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •*Adults age >18 to <75 years
- •*Patients undergoing first time elective or urgent CABG-only procedure
- •*Patients with at least 1 planned SVG
- •*Left ventricular ejection fraction (LVEF) >50%
- •*Female patients must be surgically sterile or postmenopausal
- •*Willingness, ability, and commitment to participate in a follow-up evaluation including a clinic visit at 30 days after the study procedure
排除标准
- •* In-situ IMA graft(s) only (no SVG)
- •* Prior CABG or planned concomitant valve surgery or aortic aneurysm repair
- •* Any clinically significant valve disease
- •* Left ventricular ejection fraction (LVEF) <50%
- •* Myocardial Infarction within 2 weeks of screening
- •* Creatinine >177 micro mol/l
- •* Vasculitis or another nonatherosclerotic cause of CAD
- •* Hypercoagulable state
- •* Any condition or disease detected that would render the patient unsuitable for the study
- •* Involvement in another drug or device study within 30 days
- •* Inability of the patient to provide informed consent
研究者
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