Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 816
- 试验地点
- 2
- 主要终点
- Successful navigation to the intended location
研究概览
简要总结
This prospective observational post-market clinical study will collect data in the United States to primarily support the re-launch of the re-designed Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter & Shuttle Select Slip-Catheter (Visceral and Cerbral) for a Conformité Européenne (CE) Mark application in the European Union (EU). Additionally, the data from this study may be used to support regulatory approval in other countries/regions.
The purpose of this clinical study is to evaluate the safety and performance of these catheters in accordance with the Intended Use through the end of index procedure, and through 30 days post procedure, (as applicable as data is available) to ensure an acceptable benefit:risk ratio.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient is deemed suitable for inclusion in this study if the patient undergoes a procedure using an applicable Beacon Tip Catheter.
排除标准
- •Patient or his/her legally authorized representative objects to collection and processing of his/her data, or not willing to accept the use of an Informed Consent waiver or the data protection notice (if utilized).
结局指标
主要结局
Successful navigation to the intended location
时间窗: Duration of the procedure (approx. 1 hour)
The primary performance outcome is successful navigation to the intended location The percent of successful navigation to the intended location
Successful intended use
时间窗: Duration of the procedure (approx. 1 hour)
Successful intended use (e.g. release of contrast agent (if applicable), successful anatomical sizing (if applicable)), after successful navigation to the intended location
Freedom from catheter-related major complications
时间窗: up to 30 days
The primary safety outcome is freedom from catheter-related major complications. Major complications are defined as those that: * Require therapy, minor hospitalization (\<48 hours); * Require major therapy, unplanned increase in level of care, prolonged hospitalization; * Have permanent adverse sequelae; or result in death. The percent of patients with freedom from catheter-related major complications
次要结局
未报告次要终点