Study

Peripheral Onyx Liquid Embolic Safety and Effectiveness of The Onyx LES for embolization of arterial hemorrhage in the Peripheral Vasculature

The primary effectiveness endpoint is defined as freedom from arterial hemorrhage in all target location(s) after treatment with Onyx™ LES at the index procedure without re-embolization or any other intervention at the target location(s) due to persistent or recurrent hemorrhage through 30 days. Freedom from arterial hemorrhage is the absence of an arterial hemorrhage event. An arterial hemorrhage event is defined as a type 3 or greater BARC19 bleeding criteria as assessed by the Clinical Events Committee (CEC).

Why this Research Matters

This is a prospective, multi-center, non-randomized, single arm study to evaluate the safety and effectiveness of Onyx™ LES for the embolization of arterial hemorrhage in the peripheral vasculature.

Who can Participate

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