119 Participants Needed

Onyx™ Liquid Embolic System for Peripheral Arterial Bleeding

Recruiting at 3 trial locations
EH
LM
Overseen ByLiza Marie
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic Endovascular
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

OA

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

My doctor believes I have more than 30 days to live.
I have active bleeding in my arteries that can be treated with embolization.
I am 22 years old or older.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive embolization treatment with Onyx™ LES for active arterial bleeding in the peripheral vasculature

1 day
Index procedure

Post-procedure Follow-up

Participants are monitored for safety and effectiveness, including hospital discharge and 30-day follow-up visits

30 days
2 visits (in-person)

Reintervention Monitoring

Reintervention visits are captured through 30 days post-index procedure if additional procedures are needed

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Onyx™ Liquid Embolic System
Trial Overview The Onyx™ Liquid Embolic System (LES) is being tested for its safety and effectiveness in stopping active arterial bleeding outside of the heart and brain. The study involves using this liquid embolic agent to control such bleeding.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment with Onyx LESExperimental Treatment1 Intervention
Device; embolization with liquid embolic

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic Endovascular

Lead Sponsor

Trials
70
Recruited
15,000+

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

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security