Onyx™ Liquid Embolic System for Peripheral Arterial Bleeding
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Onyx™ Liquid Embolic System to determine its safety and effectiveness in stopping active bleeding in arteries outside the brain and heart. The study targets individuals experiencing this type of bleeding who have been advised by a doctor that embolization (blocking a blood vessel) is a suitable option. Ideal candidates have recent imaging tests confirming active bleeding and have not undergone similar treatment in the same area. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from a novel treatment approach.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that the Onyx™ Liquid Embolic System is safe for treating peripheral arterial bleeding?
Research has shown that the Onyx™ Liquid Embolic System (LES) is generally safe for treating bleeding in arteries outside the heart and brain. Studies indicate that using Onyx LES, sometimes with coils, effectively stops sudden bleeding in areas like the arms or legs without causing harm.
One study found that Onyx LES is safe when used in blood vessels outside the heart and brain. The results suggest that this treatment is well-tolerated, with most people not experiencing serious side effects.
While these studies do not report any specific negative effects, the consistent findings of safety across different research studies suggest that Onyx LES is a reliable option for managing bleeding in peripheral arteries.12345Why are researchers excited about this trial?
Researchers are excited about the Onyx™ Liquid Embolic System because it offers a unique way to manage peripheral arterial bleeding. Unlike traditional treatments, which often involve surgical intervention or mechanical devices, Onyx™ is a liquid embolic agent. This means it can be precisely delivered via a catheter to the bleeding site, where it solidifies to effectively block the blood flow and promote clotting. This minimally invasive approach has the potential to reduce recovery times and complications associated with more invasive procedures.
What evidence suggests that the Onyx™ Liquid Embolic System is effective for peripheral arterial bleeding?
Research has shown that the Onyx™ Liquid Embolic System effectively treats sudden bleeding in arteries outside the heart and brain. In this trial, participants will receive treatment with the Onyx™ Liquid Embolic System. One study found that using Onyx with detachable coils is both safe and effective for this purpose. Another study highlighted that Onyx, made from a flexible plastic, can block blood flow to stop bleeding. Onyx is also easy for doctors to see on X-rays, aiding accurate use. Overall, these studies support Onyx as a promising treatment for stopping arterial bleeding.12345
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