PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 119
- 试验地点
- 25
- 主要终点
- Freedom from Arterial Hemorrhage
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.
详细描述
This is a pivotal, prospective, multi-center, non-randomized, single arm study. This study will enroll patients with active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by investigator. In this study, peripheral vasculature is defined as outside of the brain and heart.
Up to 135 subjects will be consented to achieve 119 enrolled at up to 25 sites in the US.
This study will have two visits post-index procedure including hospital discharge visit and 30-day follow-up visit. Reintervention visits will be captured through 30 days post-index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 22 years old.
- •Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.
- •In this study, peripheral vasculature is defined as outside the brain and heart.
- •Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
- •Life expectancy of >30 days, in the opinion of the investigator at the time of enrollment.
- •Target treatment area is free from prior embolization treatment.
排除标准
- •Pregnant or breastfeeding.
- •Symptoms of active infection.
- •Patient is known to be participating in the study of an investigational drug, biologic, or device.
- •Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
- •Known allergy to components of Onyx™.
- •Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
- •More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.
研究组 & 干预措施
Treatment with Onyx LES
Device; embolization with liquid embolic
干预措施: Onyx™ Liquid Embolic System (Device)
结局指标
主要结局
Freedom from Arterial Hemorrhage
时间窗: Through 30 days post-index procedure
Freedom from arterial hemorrhage in all target location(s) after treatment with Onyx™ LES at the index procedure without re-embolization or any other intervention at the target location(s) due to persistent or recurrent hemorrhage through 30 days. Freedom from arterial hemorrhage where an arterial hemorrhage event is defined as a type 3 or greater BARC bleeding criteria as assessed by the Clinical Events Committee (CEC) through 30 days.
Freedom from System-related Major Adverse Events (MAE)
时间窗: Through 30 days post-index procedure
The primary safety endpoint is defined as freedom from system-related Major Adverse Events (MAE) through 30 days after the point of enrollment as assessed by the CEC.
次要结局
- Procedural Success(At the completion of the index procedure)
- Technical Success(At the completion of the index procedure)
- Reintervention(Through 30 days post-index procedure)
- Transfusions(Through 30 days post-index procedure)