Onyx™ Liquid Embolic System for Peripheral Arterial Bleeding
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Osman Ahmed, MD
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for individuals aged 22 or older with active arterial bleeding in areas of the body excluding the heart and brain, confirmed by imaging. Participants must be able to consent and have a life expectancy over 30 days. They should not have had prior embolization treatment in the affected area.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive embolization treatment with Onyx™ LES for active arterial bleeding in the peripheral vasculature
Post-procedure Follow-up
Participants are monitored for safety and effectiveness, including hospital discharge and 30-day follow-up visits
Reintervention Monitoring
Reintervention visits are captured through 30 days post-index procedure if additional procedures are needed
What Are the Treatments Tested in This Trial?
Interventions
- Onyx™ Liquid Embolic System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Endovascular
Lead Sponsor
Geoff Martha
Medtronic Endovascular
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Simona Zannetti
Medtronic Endovascular
Chief Medical Officer since 2024
MD from University of Perugia Medical School, research fellowship in vascular surgery at Massachusetts General Hospital, Harvard Medical School