LOBO Vascular Occlusion System: LOBO Vascular Occlusion System
Study summary
This registry will provide insights into the use of Okami Medical devices in real-world clinical and study effectiveness and safety of Okami Medical devices.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* The patient or their legally authorized representative is willing and able to provide informed consent per local requirements
* Has or will receive treatment with an eligible Okami Medical device
* Age ≥ 18 years
Exclusion Criteria:
* Is or will be inaccessible for registry follow-up
* Meets exclusion criteria required by local requirements
* Current or planned participation in a drug or device study that would interfere with participation in this registry or confound the results of this registry in the opinion of the investigator
Primary outcome measure(s)
Safety Endpoint — 30 days post-index procedure Incidence of device-related serious adverse events during the index procedure
Effectiveness Endpoint — During index procedure Technical success of the LOBO Vascular Occlusion System defined as occlusion of the intended target(s) with the LOBO occluder, assessed by angiography
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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