Onyx™ Liquid Embolic IDE Clinical Study
Start Date
5/9/2025
Completion Date
5/1/2027
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.
Detailed Description
This is a pivotal, prospective, multi-center, non-randomized, single arm study. This study will enroll patients with active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by investigator. In this study, peripheral vasculature is defined as outside of the brain and heart. Up to 135 subjects will be consented to achieve 119 enrolled at up to 25 sites in the US. This study will have two visits post-index procedure including hospital discharge visit and 30-day follow-up visit. Reintervention visits will be captured through 30 days post-index procedure.
Eligibility Criteria
Age Range: 22 years to No maximum
Interventions
Onyx™ Liquid Embolic System
Conditions
Locations
Mayo Clinic
Phoenix, Arizona 85054
United States
University of California, Irvine
Irvine, California 92627
United States
Stanford Medical Center
Palo Alto, California 94304
United States
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
United States
Yale New Haven
New Haven, Connecticut 06510
United States
University of Chicago
Chicago, Illinois 60637
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United States
Masschusetts General Hospital
Boston, Massachusetts 02114
United States
CHI Health Creighton University Medical Center-Bergan-Mercy
Omaha, Nebraska 68124
United States
Rutgers New Jersey Medical School
Newark, New Jersey 07103
United States
Albany Medical Center
Albany, New York 12208
United States
The Mount Sinai
New York, New York 10029
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
The Ohio State University
Columbus, Ohio 43210
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15237
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United States
Univ Of Texas Southwestern
Dallas, Texas 75235
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States