Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.

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

Conditions
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Peripheral Arterial Hemorrhage

Intervention / Treatment
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* Device: Liquid Embolic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lava LES<br> | Device: Liquid Embolic<br>* Lava Liquid Embolic System (LES)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of freedom from Major Adverse Events (MAEs) |  | 30 Days | 
| Clinical Success | 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. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Hemorrhage, Embolic Treatment