Onyx™ Liquid Embolic IDE Clinical Study

Launched by MEDTRONIC ENDOVASCULAR · Dec 18, 2024

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ClinConnect Summary

The Onyx™ Liquid Embolic IDE Clinical Study is looking at the safety and effectiveness of a special treatment called Onyx™ for patients who are experiencing active bleeding from blood vessels outside of the brain and heart. This bleeding can happen due to various reasons, like trauma or ulcers. The study aims to determine if using Onyx™ can help stop this bleeding and improve patient outcomes.

To participate in this study, patients must be at least 22 years old and have confirmed active bleeding that can be treated with a procedure called embolization, which blocks off the bleeding blood vessel. Patients also need to be able to give written consent to join the study and their doctors should believe they have a reasonable chance of living for more than 30 days. It's important to note that the study is not open for enrollment yet, and certain conditions—like being pregnant or having an infection—may prevent someone from participating. If eligible, participants can expect to undergo the embolization procedure and be closely monitored for their safety and recovery.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is ≥ 22 years old.
• • 2. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.
• • In this study, peripheral vasculature is defined as outside the brain and heart.
• • 3. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
• • 4. Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment.
• • 5. Target treatment area is free from prior embolization treatment.
• Exclusion Criteria:
• • 1. Pregnant or breastfeeding.
• • 2. Symptoms of active infection.
• • 3. Patient is known to be participating in the study of an investigational drug, biologic, or device.
• • 4. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
• • 5. Known allergy to components of Onyx™.
• • 6. Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
• • 7. More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.