NCT06742801 · Medtronic Endovascular
Onyx™ Liquid Embolic IDE Clinical Study
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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 measures
Freedom from Arterial Hemorrhage
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient is ≥ 22 years old.
- 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.
- Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
- Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment.
- Target treatment area is free from prior embolization treatment.
Exclusion criteria
- Pregnant or breastfeeding.
- Symptoms of active infection.
- Patient is known to be participating in the study of an investigational drug, biologic, or device.
- Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
- Known allergy to components of Onyx™.
- Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
- More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.
Where
- Phoenix, Arizona
- Irvine, California
- Palo Alto, California
- Aurora, Colorado
- New Haven, Connecticut
- Chicago, Illinois
- Iowa City, Iowa
- Boston, Massachusetts
- Omaha, Nebraska
- Newark, New Jersey
- Albany, New York
- New York, New York
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2026 · Source of record for eligibility and locations