Liquid Embolization of Arterial Hemorrhages in the Peripheral Vasculature: The LAVA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 18
- 主要终点
- Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)
研究概览
简要总结
To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Active arterial bleeding in the peripheral vasculature, documented on a suitable imaging study;
- •Subject or subject's legally authorized representative is able and authorized to provide written informed consent for the procedure and the study;
- •Subject is willing and able to comply with the specified follow-up evaluation schedule;
- •Life expectancy >30 days;
- •No prior embolization in the target territory.
排除标准
- •Pregnancy or breast feeding. A woman who, in the Investigator's opinion, is of child-bearing potential must have a negative pregnancy test within 7 days before the index procedure;
- •Coexisting signs of peritonitis or other active infection;
- •Participation in an investigational study of a new drug, biologic or device that has not reached its primary endpoint at the time of study screening;
- •Uncorrectable coagulopathies such as thrombocytopenia <40,000/ μL, international normalization ratio (INR) >2.0;
- •Contraindication to angiography or catheterization, including untreatable allergy to iodinated contrast media;
- •Anatomic arterial unsuitability such that, in the Investigator's opinion, the delivery catheter cannot gain access to the selected position for safe and intended embolization;
- •Known allergy or other contraindication to any components of Lava LES including dimethyl sulfoxide (DMSO);
- •More than 4 Target Lesions will require embolization, in the Investigator's opinion after performance of diagnostic angiography or another suitable imaging study.
结局指标
主要结局
Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)
时间窗: 30 Days
A composite of freedom from 30-day MAEs include ischemia or infarction of the target territory, non-target embolization, allergic reactions to Lava, catheter breakage, and catheter entrapment defined as the inability to withdraw a catheter from adherence to Lava.
Percentage of Lesions to Achieve Clinical Success
时间窗: 30 days
Defined as absence of bleeding from the target lesion after embolization with the Lava LES, without the need for emergency surgery, re-embolization, or other target lesion reinterventions.
次要结局
未报告次要终点