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Onyx™ Liquid Embolic IDE Clinical Study

Recruiting

PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature

Who can join

Ages 22 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Medtronic Endovascular · Participants: 119 · Started: May 9, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06742801

Locations in the U.S.

ArizonaMayo Clinic, Phoenix
CaliforniaUniversity of California, Irvine, Irvine
Stanford Medical Center, Palo Alto
ColoradoUCHealth University of Colorado Hospital, Aurora
ConnecticutYale New Haven, New Haven
IllinoisUniversity of Chicago, Chicago
IowaUniversity of Iowa Hospitals and Clinics, Iowa City
MassachusettsMasschusetts General Hospital, Boston
NebraskaCHI Health Creighton University Medical Center-Bergan-Mercy, Omaha
New JerseyRutgers New Jersey Medical School, Newark
New YorkAlbany Medical Center, Albany
The Mount Sinai, New York
North CarolinaUniversity of North Carolina at Chapel Hill, Chapel Hill
OhioUniversity Hospitals Cleveland Medical Center, Cleveland
The Ohio State University, Columbus
PennsylvaniaUniversity of Pittsburgh Medical Center, Pittsburgh
TennesseeVanderbilt University Medical Center, Nashville
TexasUniv Of Texas Southwestern, Dallas
The University of Texas Health Science Center at Houston, Houston

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.