This study looks at whether a new product called Onyx LES is safe and works well when doctors use it to stop bleeding in blood vessels outside the brain and heart in adults that have arterial hemorrhage in the peripheral blood vessels.
We are looking for adults with bleeding from a damaged artery outside the brain and heart to join our study. Arteries are blood vessels that carry blood away from the heart. Blood vessels outside of the brain and heart are called peripheral blood vessels. If you choose to join this study and are eligible, you may get a procedure called embolization using a product called Medtronic’s Onyx™ Liquid Embolic System (Onyx LES). Embolization is a minimally invasive procedure that helps stop blood flow in specific areas of the body. Onyx LES is not approved by the FDA for use in blood vessels outside the brain and heart. You will have a study visit to see if you qualify. During this visit, the study team will review your medical history and collect your basic information from you, like your age and sex. A blood sample will be taken from a vein in your arm. You also will have standard medical imaging to check the bleeding. If you qualify, you will be admitted to the hospital for the procedure. During the procedure, the doctor will use a thin tube called a catheter to place Onyx LES directly into the damaged peripheral blood vessels. When the liquid comes into contact with blood, it hardens to a spongy texture. This spongy material fills the damaged area of the blood vessel and helps stop the bleeding. X-ray imaging will be used to guide the catheter to the correct location. After the procedure, X-ray imaging will be taken to look at the treated blood vessels and another blood sample will be collected. You will then be discharged from the hospital. The study staff will contact you 30 days after the procedure to see how you are doing and to ask if you have had any side effects. You will have three study visits. Two visits will be in person, and one will be done over the phone. Your participation in the study will last about 1 month after the procedure. You will not be paid for being in this study. You and your insurance will need to pay for your routine medical care.
You may be able to join this study if you are at least 22 years old and have arterial bleeding in blood vessels outside the brain and heart. You must be expected to live longer than 30 days and you must not have received embolization in the same area before. You cannot join if you have an active infection or allergies to contrast dye or ingredients of Onyx LES.
Protocol Number: 24-1860
More information available at ClinicalTrials.gov: NCT06742801
Principal Investigator