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

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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Hemorrhage
• Intervention / Treatment: Device: Liquid Embolic

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • New York
    • Albany, New York, United States, 12208
      • Albany University Medical Center
    • New York, New York, United States, 10029
      • Icahn School Of Medicine At Mount Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lava LES	Device: Liquid Embolic; Lava Liquid Embolic System (LES)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 days

Collaborators and Investigators

• Sponsor: BlackSwan Vascular, Inc.
• Collaborators: Syntactx
• Investigators: Principal Investigator: Bulent Arslan, MD, Rush University Medical Center; Principal Investigator: Mahmood Razavi, MD, St. Joseph Heart and Vascular Center

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral Arterial Hemorrhage; Embolic Treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: TPR-00913-01.A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes