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

NCT04649255 | Completed Results DMC FDA Device

• 1 other identifier: TPR-00913-01.A
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Peripheral Arterial Hemorrhage

Keywords

Peripheral Arterial Hemorrhage; Embolic Treatment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Lava LES

EXPERIMENTAL

Device: Liquid Embolic

Interventions

Liquid Embolic DEVICE

Lava Liquid Embolic System (LES)

Lava LES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• BlackSwan Vascular, Inc.: lead
• Syntactx: collaborator

Study Sites (9)

University of California

Irvine, California, 92697, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Albany University Medical Center

Albany, New York, 12208, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

• Title: Janet Bell
• Organization: Sirtex Medical

jbell@sirtex.com

+ 888-474-7839

Study Officials

• Bulent Arslan, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Mahmood Razavi, MD

  St. Joseph Heart and Vascular Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 2, 2020
• Study Start: April 14, 2021
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)