Recruiting

Onyx™ Liquid Embolic

Sponsor:

Medtronic Endovascular

Code:

NCT06742801

Conditions

Peripheral Arterial Hemorrhage

Trauma

GI Bleed

Ulcer

Hemorrhage

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Onyx™ Liquid Embolic System

Study Details

Brief 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.

Conditions

Peripheral Arterial Hemorrhage

Trauma

GI Bleed

Ulcer

Hemorrhage

Study ID

NCT06742801

Start date

May 9, 2025

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

119 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment with Onyx LES

Device; embolization with liquid embolic

Interventions

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.

Primary outcome measure

  • Freedom from Arterial Hemorrhage [ Time Frame: Through 30 days post-index procedure ]
  • Freedom from System-related Major Adverse Events (MAE) [ Time Frame: Through 30 days post-index procedure ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Principal Investigator:

Sadeer Alzubaidi, MD

University of California, Irvine

Recruiting

Irvine, California, United States, 92627

Contacts

Nadine Jaoudeh, MD

nadine@hs.uci.edu

Stanford Medical Center

Recruiting

Palo Alto, California, United States, 94304

UCHealth University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Alejandra Aguilar, MPH

alejandra.aguilar@cuanschutz.edu

Principal Investigator:

Eduardo Bent Robinson, MD

Yale New Haven

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Angelo Marino, MD

angelo.marino@yale.edu

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Brian Funaki, MD

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Michael Hummel, MD

Masschusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

CHI Health Creighton University Medical Center-Bergan-Mercy

Recruiting

Omaha, Nebraska, United States, 68124

Contacts

Principal Investigator:

Patrick Harty

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Gary Siskin, MD

sisking@amc.edu

Nancy Spencer, NP

spencen@amc.edu

The Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Salim Abboud, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Suzanne Burdin

burdins@upmc.edu

Principal Investigator:

Paula Novelli, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Principal Investigator:

Anthony Borgmann, MD

Univ Of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Sanjeeva Kalva, MD

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Rodrick Zvavanjanja, MD

More Information

Sponsor

Medtronic Endovascular

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Peripheral Arterial Hemorrhage
  • Embolization treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medtronic Endovascular on 2026-07-24.