Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Keywords

Peripheral Arterial Hemorrhage Embolic Treatment Hemorrhage Liquid Embolic Lava LES

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California accepting new patients
    Irvine California 92697 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BlackSwan Vascular, Inc.
ID
NCT04649255
Study Type
Interventional
Last Updated