Randomized Clinical Evaluation of LeGoo™ Internal Vessel Occluder Vs Traditional Vessel Loops
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The primary research hypothesis is that surgeons will obtain a bloodless surgical field and achieve satisfactory hemostasis in a larger proportion of anastomoses using LeGoo™ than using a conventional temporary hemostasis technique.
研究概览
简要总结
The primary purpose of this study is to demonstrate the clinical safety and efficacy of LeGoo™ in comparison to a standard vessel occlusion method (i.e. vessel loops). Although LeGoo™ is suitable for use in any vascular surgery where temporary vessel occlusion is desired, this study specifically focuses on the use of LeGoo™ in off-pump coronary bypass (OPCAB), as a most sensitive model of adverse changes that may occur at any vascular site.
详细描述
The purpose of this study is to evaluate the clinical efficacy of LeGoo™ as compared to a traditional vessel loop. LeGoo is a device that is intended to be used during surgical procedures to temporarily occlude blood vessels while forming an anastomosis. LeGoo™ will be evaluated in subjects undergoing off-pump coronary artery by-pass (OPCAB) surgery. This is a prospective, randomized trial with a 30-day follow-up period. Half of the eligible patients will be randomized to the experimental group (LeGoo™); and the other half to the control group (standard vessel loops).
LeGoo™ is polymer-based device which is comprised of a non-toxic and biocompatible gel that exists as a liquid at low temperatures and rapidly transitions to a solid at body temperature, forming a plug that can occlude blood vessels. LeGoo™ is injected into a blood vessel that is intended to be occluded, where it stays in a "plug" form for several minutes allowing the surgeon to work in a bloodless field. The gel dissolves with time (spontaneously) or can be reversed back to liquid instantly by cooling the site with ice or irrigating with cold saline. Once dissolved below a minimum concentration, the polymer can never re-solidify.
The primary research hypothesis is that surgeons will obtain a bloodless surgical field and achieve satisfactory hemostasis in a larger proportion of anastomoses using LeGoo™ than using a conventional temporary hemostasis technique.
Satisfactory hemostasis is defined by the surgeon who will quantitate his/her observation about the quality of the surgical field using the following scoring system:
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- Excellent hemostasis (no bleeding)
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- Minimal bleeding (bleeding does not interfere with suturing)
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- Modest bleeding (required intermittent use of another device to control bleeding at the site of the anastomosis)
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- Copious bleeding (required continuous use of another device)
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing elective off pump coronary artery bypass (OPCAB) surgery where the surgeon prospectively plans to use a vascular occlusion device.
- •>70% proximal stenosis of at least one target coronary artery, other than left main
- •Age: between the ages 18 -79 years
- •Gender: male and female
- •Subject is willing and able to participate in a clinical research study and provides informed consent.
- •Subject is able and willing to participate in required follow-up procedures.
排除标准
- •Previous cardiac surgery.
- •Left ventricular dysfunction (EF <40%)
- •>50% of left main coronary artery stenosis
- •Subjects with a logistic EuroScore equal to or greater than 10% as calculated by the euroscore.org calculator
- •Emergent Surgery: Subjects undergoing surgery before the start of the next working day following catheterization
- •Creatinine > 200 µmol/L
- •Bilirubin > 21 µmol/L
- •Subjects with chronic pulmonary disease [ FEV1 < 45% ]
- •Any subject who is deemed by the investigator, for any reason, not suitable or able to participate in a clinical research study.
- •Pregnant women. Women of childbearing age will require a pregnancy test within 10 days of the operation and will be excluded if the result is positive.
- •Women who are lactating.
- •Subjects who have undergone other investigational therapy within 30 days prior to the operation or who are scheduled to receive investigational therapy within six months of the operation.
- •Subjects suspected to have one intra-myocardial artery among the coronary arteries to be bypassed during that surgery.
结局指标
主要结局
The primary research hypothesis is that surgeons will obtain a bloodless surgical field and achieve satisfactory hemostasis in a larger proportion of anastomoses using LeGoo™ than using a conventional temporary hemostasis technique.
时间窗: in operating room
次要结局
- Total duration of the anastomosis, blood loss during the surgery, Time required to occlude the vessel, the number of units of blood transfused during hospitalization.(in operating room (day of surgery))
- Safety will be measured by comparing a composite of four serious adverse events experienced by the treated and control groups: death, graft occlusion, myocardial damage, and low post procedure cardiac output.(one month post op)