The Robotic Vascular and Endovascular Registry (ROVER)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 348
- 试验地点
- 7
- 主要终点
- Effectiveness
研究概览
简要总结
The purpose of the registry is to gather both retrospective and prospective case data on the use of the commercially available Magellan Robotic System and Magellan Robotic Catheters in accordance with the approved intended use. For prospective cases, follow-up patient data will be collected at 14 days (± 5 days) post procedure to assess treatment success, primary patency of intended targeted vessel region, and adverse events.
The data will be analyzed for medical education, societal presentation, and/or publication by the investigators.
Over the next 2+ years, physicians who meet the selection criteria will be invited to participate in the registry.
详细描述
The objectives of the study are to allow the physician to use the commercially available Magellan Robotic System and Magellan Robotic Catheters to navigate to the treatment targets in the peripheral vasculature to:
-
Determine the number of endovascular procedures consecutively performed with the Magellan Robotic System to navigate to treatment targets in the peripheral vasculature and,
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Achieve stable and efficient system preparation and set-up times, navigation and cannulation times of target vessels during endovascular procedures, and placement of therapeutic equipment used to perform endovascular procedures.
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Achieve stable and reduced fluoroscopy time during the endovascular procedures.
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Determine the number of cases required to reach a "steady state," reduction or predictable time in conducting peripheral interventional procedures using descriptive (means, ranges) statistics to analyze the data.
Design
This is a prospective and retrospective, multi-center, single arm, non-blinded, sequentially enrolling data collection activity (for which Hansen Medical is providing funding). Only patients scheduled to undergo endovascular procedures using the Magellan Robotic System will be approached for enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Must be at least 18 years of age;
- •Able and willing to provide written informed consent;
- •Eligible for minimally invasive or endovascular treatment in the peripheral vasculature;
- •Not participating in an investigational study involving the peripheral vasculature.
排除标准
- •Disease targeted for treatment in the coronary vasculature or intra-cerebral vasculature;
- •Vasculature that cannot accommodate the Magellan™ Robotic Catheter or required accessories;
- •The required delivery of therapeutic device(s) through the Magellan Robotic Catheter in which the diameter for the therapeutic device(s) is/are incompatible with the Magellan Robotic Catheter;
- •An endovascular approach to the treatment of peripheral vasculature disease is contraindicated.
- •Patients who are prisoners.
- •Patients who are mentally incapacitated, e.g., comatose, unresponsive, cannot provide informed consent, or deemed unreliable or unstable by the investigator.
- •Patients with a cognitive impairment.
结局指标
主要结局
Effectiveness
时间窗: 14 days post procedure
Consistent manual delivery of therapeutic devices to the target vessel area in the peripheral vasculature by the physician.
Safety
时间窗: 14 days post procedure
Incidence and description of device-related (Magellan Robotic System only) adverse events through the follow up period.
次要结局
未报告次要终点