Okami Medical Comprehensive Registry Platform
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 500
- Locations
- 4
- Primary Endpoint
- Safety Endpoint
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Analysis Population 1
Patients treated for the control of peripheral arterial bleeding/hemorrhage.
Intervention: LOBO Vascular Occlusion System (Device)
Analysis Population 2
Patients treated for pulmonary arteriovenous malformations.
Intervention: LOBO Vascular Occlusion System (Device)
Analysis Population 3
Patients treated with the LOBO Vascular Occlusion System.
Intervention: LOBO Vascular Occlusion System (Device)
Outcomes
Primary Outcomes
Safety Endpoint
Time Frame: 30 days post-index procedure
Incidence of device-related serious adverse events during the index procedure
Effectiveness Endpoint
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported