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.
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 will be captured through 30 days post-index procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
119
The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.
Mayo Clinic
Phoenix, Arizona, United States
RECRUITINGUniversity of California, Irvine
Irvine, California, United States
Freedom from Arterial Hemorrhage
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 where an arterial hemorrhage event is defined as a type 3 or greater BARC bleeding criteria as assessed by the Clinical Events Committee (CEC) through 30 days.
Time frame: Through 30 days post-index procedure
Freedom from System-related Major Adverse Events (MAE)
The primary safety endpoint is defined as freedom from system-related Major Adverse Events (MAE) through 30 days after the point of enrollment as assessed by the CEC.
Time frame: Through 30 days post-index procedure
Procedural Success
successful delivery and deployment of Onyx™ to the target location without non-target embolization or Onyx™ cast migration and the successful removal of the delivery system at the completion of the index procedure.
Time frame: At the completion of the index procedure
Technical Success
Technical Success is defined as absence of angiographic signs of bleeding after Onyx ™ embolization at each target location based on core lab assessment.
Time frame: At the completion of the index procedure
Reintervention
Reintervention is defined as the number of additional procedures needed to treat the target location(s) embolized with Onyx™ through 30 days following the index procedure.
Time frame: Through 30 days post-index procedure
Transfusions
Transfusions defined as the number of blood transfusions required post-index procedure through 30 days will use blood transfusions starting after the removal of the delivery system. The number of blood units used for each transfusion will also be collected.
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Stanford Medical Center
Palo Alto, California, United States
RECRUITINGUCHealth University of Colorado Hospital
Aurora, Colorado, United States
RECRUITINGYale New Haven
New Haven, Connecticut, United States
RECRUITINGUniversity of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
RECRUITINGMasschusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGCHI Health Creighton University Medical Center-Bergan-Mercy
Omaha, Nebraska, United States
RECRUITINGAlbany Medical Center
Albany, New York, United States
RECRUITINGThe Mount Sinai
New York, New York, United States
RECRUITING...and 4 more locations
Time frame: Through 30 days post-index procedure