The RAVI Registry: A Prospective, Multi-Center, Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 6
- 主要终点
- Procedural Success
研究概览
简要总结
This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.
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
- •Subject is ≥ 18 years old
- •Subject is scheduled for a procedure for treatment with HydroPearl microspheres using radial access.
- •Subject is willing and able to complete follow-up requirements
- •Subject is willing and able to sign a written Informed Consent form prior to participating in the registry.
排除标准
- •Unable to have a procedure with radial access for any reason.
- •Participating in another clinical study which, in the opinion of the investigator, could impact the results of this registry.
- •Pregnant or planning to become pregnant during the study.
结局指标
主要结局
Procedural Success
时间窗: Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))
Defined as completing the planned procedure without femoral access bailout
Technical Success
时间窗: Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed)
Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization
Freedom From Major Adverse Events and Radial Access Complications
时间窗: within 30 days post-procedure
Major Adverse Events are defined as the following: Death MI Stroke
Radial Access Related Complications Within 30 Days
时间窗: 30 days post procedure
Radial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following: Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure
次要结局
未报告次要终点