Onyx™ Liquid Embolic IDE Clinical Study

Recruiting now · Not applicable

Conditions studied: Peripheral Arterial Hemorrhage, Trauma, GI Bleed, Ulcer, Hemorrhage

In brief

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.

Key facts

Study ID

NCT06742801

Run by

Medtronic Endovascular

People needed

119

Starts

2025-05-09

Expected to finish

2027-05-01

Last updated by the study team

2026-07-24

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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