Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Overall Perioperative Complications Between Selective vs. Routine Shunting.
研究概览
简要总结
The project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA) to see the difference in post-op complications and occurence rates. Patients will be randomized to Routine shunt vs selective groups.
详细描述
The significance extends to all surgeons who perform Carotid endarterectomy because of their desire to improve patient care by decreasing the overall perioperative complication rate of the procedure by selectively not shunting those patients who ideally do not require it and thus eliminating the attendant morbidity associated with it.
The hypothesis is that there will be no difference in patient outcomes (death, minor strokes, major strokes, transient ischemic attack (TIA)) for patients undergoing a Carotid endarterectomy with a SP of > 50 mm Hg using selective shunting.Patients will be randomized to Routine shunt vs selective groups. In Selective shunt, there will be subgroup analysis to measure % stenosis if the systolic pressure is < 40mmHg calling it as Shunt group. All patients in the study, irrespective of treatment group will be followed post-operatively from 24 hours to 30 days. The patient will be monitored and the following outcomes documented - death, minor stroke, major stroke, trans-ischemic attack (TIA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a SP >= 50 mmHg will be randomized to receive a shunt or not receive a shunt.
排除标准
- •Patients that will be excluded are those who present for a redo CEA, have had a coronary artery bypass graft (CABG), permanent stroke, and or a contralateral artery total occlusion of > 30%.
- •Finally, consented patients with a stump pressure of <= 50 mm Hg will be excluded from the study and receive standard of care.
研究组 & 干预措施
Routine Shunt
These patients are called routine as the routine method of carotid endarterectomy is used.
干预措施: Carotid endarterectomy with routine shount (Procedure)
Selective Shunt
These patients are selectively used for shunting or not shunting based on systolic pressure < 40mmHg. This group is further used as subgroup analysis.
干预措施: Carotid endarterectomy with selective shunt (Procedure)
结局指标
主要结局
Overall Perioperative Complications Between Selective vs. Routine Shunting.
时间窗: Within 30 days of enrollment
perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction \[MI\], or asymptomatic carotid thrombosis or congestive heart failure.
次要结局
未报告次要终点
研究者
Ali AbuRahma
Ali Fawzi AbuRahma MD, Vascular Center of Excellence(CAMC Medical Staff - with admitting privileges).
CAMC Health System