Actively Recruiting
Onyx™ Liquid Embolic IDE Clinical Study
Led by Medtronic Endovascular · Updated on 2026-05-01
119
Participants Needed
16
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Onyx™ Liquid Embolic IDE Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 63; 22 years old.
- Active arterial bleeding in peripheral vasculature confirmed by radiologic and/or endoscopic imaging and suitable for embolization treatment.
- Patient or legally authorized representative can provide written consent.
- Life expectancy greater than 30 days as judged by investigator.
- Target treatment area has not received prior embolization treatment.
You will not qualify if you...
- Pregnant or breastfeeding.
- Symptoms of active infection.
- Currently participating in another investigational study involving drug, biologic, or device.
- Allergy or contraindication to contrast agents used in angiography, CT, or catheterization.
- Known allergy to components of Onyx14.
- Target vasculature judged unsuitable for Onyx14 delivery.
- More than 4 target lesions require embolization according to investigator's assessment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
University of California, Irvine
Irvine, California, United States, 92627
Actively Recruiting
3
Stanford Medical Center
Palo Alto, California, United States, 94304
Actively Recruiting
4
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Yale New Haven
New Haven, Connecticut, United States, 06510
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
7
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Masschusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
CHI Health Creighton University Medical Center-Bergan-Mercy
Omaha, Nebraska, United States, 68124
Actively Recruiting
10
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
11
The Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
12
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
13
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
14
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
15
Univ Of Texas Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
16
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Janki Shah
CONTACT
L
Liza Marie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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