Onyx™ Liquid Embolic IDE Clinical Study

NCT06742801 · tracked via the Priya Life Science USA tracker

Sponsor

Medtronic Endovascular

Phase

Not applicable

Started

2025-05-09

Last updated

2026-09-10

Condition(s) studied

Peripheral Arterial HemorrhageTraumaGI BleedUlcerHemorrhage

Investigational drug(s) / intervention(s)

Onyx™ Liquid Embolic System

Onyx™ Liquid Embolic System: The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.

Study summary

The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.

Eligibility

Sex

ALL

Min age

22 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patient is ≥ 22 years old. 2. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator. In this study, peripheral vasculature is defined as outside the brain and heart. 3. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study. 4. Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment. 5. Target treatment area is free from prior embolization treatment. Exclusion Criteria: 1. Pregnant or breastfeeding. 2. Symptoms of active infection. 3. Patient is known to be participating in the study of an investigational drug, biologic, or device. 4. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure. 5. Known allergy to components of Onyx™. 6. Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment. 7. More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.

Primary outcome measure(s)

Freedom from Arterial Hemorrhage — Through 30 days post-index procedure
Freedom from arterial hemorrhage in all target location(s) after treatment with Onyx™ LES at the index procedure without re-embolization or any other intervention at the target location(s) due to persistent or recurrent hemorrhage through 30 days. Freedom from arterial hemorrhage where an arterial hemorrhage event is defined as a type 3 or greater BARC bleeding criteria as assessed by the Clinical Events Committee (CEC) through 30 days.
Freedom from System-related Major Adverse Events (MAE) — Through 30 days post-index procedure
The primary safety endpoint is defined as freedom from system-related Major Adverse Events (MAE) through 30 days after the point of enrollment as assessed by the CEC.

Trial sites (19)

Facility	City	Region	Status
Mayo Clinic	Phoenix	Arizona	Recruiting
University of California, Irvine	Irvine	California	Recruiting
Stanford Medical Center	Palo Alto	California	Recruiting
UCHealth University of Colorado Hospital	Aurora	Colorado	Recruiting
Yale New Haven	New Haven	Connecticut	Recruiting
University of Chicago	Chicago	Illinois	Recruiting
University of Iowa Hospitals and Clinics	Iowa City	Iowa	Recruiting
Masschusetts General Hospital	Boston	Massachusetts	Recruiting
CHI Health Creighton University Medical Center-Bergan-Mercy	Omaha	Nebraska	Recruiting
Rutgers New Jersey Medical School	Newark	New Jersey	Suspended
Albany Medical Center	Albany	New York	Recruiting
The Mount Sinai	New York	New York	Recruiting
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	Recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	Recruiting
The Ohio State University	Columbus	Ohio	Recruiting
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	Recruiting
Univ Of Texas Southwestern	Dallas	Texas	Recruiting
The University of Texas Health Science Center at Houston	Houston	Texas	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06742801 on ClinicalTrials.gov ↗ ← All trials in the USA