Open Actively Recruiting

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

About

Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
21-000898
Category
Radiological Sciences
Contact
Stephanie Gilbert
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04649255
For detailed technical eligibility, visit ClinicalTrials.gov.