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Onyx™ Liquid Embolic IDE Clinical Study
Sponsor: Medtronic Endovascular
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.
Official title: PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
119
Start Date
2025-05-09
Completion Date
2026-12
Last Updated
2026-03-05
Healthy Volunteers
No
Interventions
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.
Locations (14)
Mayo Clinic
Phoenix, Arizona, United States
University of California, Irvine
Irvine, California, United States
Stanford Medical Center
Palo Alto, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven
New Haven, Connecticut, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Masschusetts General Hospital
Boston, Massachusetts, United States
CHI Health Creighton University Medical Center-Bergan-Mercy
Omaha, Nebraska, United States
Albany Medical Center
Albany, New York, United States
The Mount Sinai
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Univ Of Texas Southwestern
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States