PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature
Medtronic Endovascular
Summary
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.
Description
This is a pivotal, prospective, multi-center, non-randomized, single arm study. This study will enroll patients with active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by investigator. In this study, peripheral vasculature is defined as outside of the brain and heart. Up to 135 subjects will be consented to achieve 119 enrolled at up to 25 sites in the US. This study will have two visits post-index procedure including hospital discharge visit and 30-day follow-up visit. Reintervention visits…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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. Exclus…
Interventions
- DeviceOnyx™ Liquid Embolic System
The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.
Locations (16)
- Mayo ClinicPhoenix, Arizona
- University of California, IrvineIrvine, California
- Stanford Medical CenterPalo Alto, California
- UCHealth University of Colorado HospitalAurora, Colorado
- Yale New HavenNew Haven, Connecticut
- University of ChicagoChicago, Illinois