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

BlackSwan Vascular

Status

Completed

Conditions

Peripheral Arterial Hemorrhage

Treatments

Device: Liquid Embolic

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

TPR-00913-01.A

Details and patient eligibility

About

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

Enrollment

113 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.