To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds.
A Prospective Multicenter Single-Arm Staged Study to Evaluate the Safety and Effectiveness of Embrace™ Hydrogel Embolic For Transcatheter Embolization of Arterial Bleeding in Solid Organs and Peripheral Arteries
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
The Embrace Hydrogel Embolic System (HES) is indicated for embolization of peripheral arterial bleeds in vessels ≤6mm
Banner Health
Phoenix, Arizona, United States
Primary safety endpoint
Freedom from major adverse events (MAE)
Time frame: Through 30 days post-index procedure
Clinical Success
Defined as the absence of bleeding from the target lesion after embolization with Embrace HES without the need for subsequent embolic devices in the index procedure, emergency surgery, re-embolization or other target vessel re-interventions due to rebleeding.
Time frame: Within 30 days of the index procedure
Technical Success
Defined as occlusion of the target vessel or exclusion of the area of arterial damage and/or the cessation of extravasation on angiography after embolization with Embrace HES.
Time frame: Immediately following index procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Evanston, Illinois, United States
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Indianapolis, Indiana, United States
...and 12 more locations