Onyx™ Liquid Embolic IDE Clinical Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorMedtronic Endovascular
About this trial
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.
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Onyx™ Liquid Embolic System
Treatment groups
119 Participants
are divided into 1 treatment groupLocations
18Arizona
Mayo Clinic85054, Phoenix United States
California
University of California, Irvine92627, Irvine United States
Stanford Medical Center94304, Palo Alto United States
Colorado
UCHealth University of Colorado Hospital80045, Aurora United States
Sponsors and collaborators
Medtronic Endovascular
Lead sponsor
Source ClinicalTrials.gov