To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
113
Lava Liquid Embolic System (LES)
University of California
Irvine, California, United States
University of Southern California
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
Rush University Medical Center
Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)
A composite of freedom from 30-day MAEs include ischemia or infarction of the target territory, non-target embolization, allergic reactions to Lava, catheter breakage, and catheter entrapment defined as the inability to withdraw a catheter from adherence to Lava.
Time frame: 30 Days
Percentage of Lesions to Achieve Clinical Success
Defined as absence of bleeding from the target lesion after embolization with the Lava LES, without the need for emergency surgery, re-embolization, or other target lesion reinterventions.
Time frame: 30 days
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Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
Albany University Medical Center
Albany, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States