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

NCT04649255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2024-04-12

Study results available
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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

Interventions

DEVICE

Liquid Embolic

Lava Liquid Embolic System (LES)

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • BlackSwan Vascular, Inc.

    lead INDUSTRY

Principal Investigators

  • Bulent Arslan, MD · Rush University Medical Center

  • Mahmood Razavi, MD · St. Joseph Heart and Vascular Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2022-08-17
Completion
2022-08-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04649255 on ClinicalTrials.gov