Ensayos clínicos

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.

Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.