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Clinical Trials in the USA / NCT06742801
Recruiting Not applicable

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
2026-10-13

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
No
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 (20)

FacilityCityRegionStatus
Mayo Clinic Phoenix Arizona Recruiting
University of California, Irvine Irvine California Recruiting
University of California Los Angeles Los Angeles 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 Recruiting
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