Arterial Bleed, Embolization, Hemorrhage, Pulmonary Arteriovenous Malformation
Conditions
Brief 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.
Interventions
DEVICELOBO Vascular Occlusion System
LOBO Vascular Occlusion System
Sponsors
Okami Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed