Liquid Embolization of Arterial Hemorrhages in the Peripheral Vasculature: The LAVA Study

BlackSwan Vascular, Inc.9 个研究点分布在 1 个国家目标入组 113 人2021年4月14日

适应症Peripheral Arterial Hemorrhage

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Peripheral Arterial Hemorrhage
发起方: BlackSwan Vascular, Inc.
入组人数: 113
试验地点: 9
主要终点: Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)
状态: 已完成
最后更新: 2年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2021年4月14日

结束日期

2022年8月17日

最后更新

2年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

BlackSwan Vascular, Inc.

责任方

Sponsor

入排标准

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.