NCT01136811终止不适用
Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Patency of Graft Anastomosis
研究概览
简要总结
The purpose of this study is to evaluate the preliminary safety and efficacy of the daVinci surgical system (computer-assisted surgery) for use in vascular surgery procedures. Although the daVinci Surgical System is FDA approved and widely used for surgical procedures for urology, cardiac, general, and gynecologic procedures, it is not currently approved specifically for use in vascular surgery and the FDA has required the PI to conduct a small feasibility study under an IDE. The investigators are seeking approval by the FDA to utilize the daVinci Surgical System in vascular surgery and to conduct a future clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with significant femoropopliteal or tibial occlusive disease not amenable to catheter directed therapy (ie angioplasty/stenting). Symptoms include lifestyle-limiting claudication, rest pain and/or tissue loss.
- •Patients with an ABI between 0.2 and 0.
- •Femoropopliteal disease visible on color duplex ultrasound (DUS)
- •Patent and minimally diseased common femoral and proximal superficial artery
- •Patients with American Society of Anesthesiology (ASA) I, II or III classification
- •PT/PTT, EKG, HbA1c, liver function, within normal ranges within 30 days prior to procedure or stable over the last 6 months.
- •Current University of Chicago Medical Center Lab standards will be used. Pulmonary function will be assessed as needed by preoperative anesthesia evaluation. (Generally for infrainguinal procedures, pulmonary function is not assessed)
- •Body Mass Index (BMI) <40
排除标准
- •Previous surgery in the inguinal region (ie: prior femoral artery dissection)
- •Myocardial infarction (MI) within the last 6 months
- •Laboratory evidence of hypercoagulable state and/or connective tissue disease
- •Pregnant women
- •History of non-compliance with medical care
结局指标
主要结局
Patency of Graft Anastomosis
时间窗: 30 Day
次要结局
- Death(30day, 1 year)
- Time for Femoral Artery Dissection and Anastomosis(1 day)
- Improvement in ABI Measurement of 0.15 or Better(3 month, 6 month, 1 year)
研究者
研究点 (4)
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