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

ID#: NCT04649255

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: April 14, 2021

End Date: March 01, 2022

Contact Information:
BlackSwan Clinical Affairs
(510) 877-1441
Summary: To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.

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.