ClotTriever® Thrombectomy System Use-Result Survey in Japan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Inari Medical
- Enrollment
- 100
- Locations
- 15
- Primary Endpoint
- Rate of Major Adverse Events
Study Overview
Brief Summary
The objective of this survey is to determine the safety and efficacy of the ClotTriever Thrombectomy System under daily clinical practice after marketing approval in Japan.
This device was designated as a subject of use results evaluation at the time of application for manufacturing and marketing approval.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •This is an all-comers survey of all patients treated with ClotTriever® Thrombectomy System in Japan.
Exclusion Criteria
- Not provided
Arms & Interventions
Full Analysis Population
All subjects who the survey device entered their vasculature.
Intervention: ClotTriever® Thrombectomy System (Device)
Outcomes
Primary Outcomes
Rate of Major Adverse Events
Time Frame: Through 30 days post index procedure.
Rate of Major Adverse Events \[All-cause mortality, Major bleeding, New symptomatic Pulmonary Embolism (PE) documented by Computed Tomography Pulmonary Angiography (CTPA), Rethrombosis of a Target Venous Segment\].
Technical Success
Time Frame: During the index procedure
Thrombus residual volume assessed by the the treating physician using pre- and post-procedure venography to evaluate the success of thrombus removal.
Secondary Outcomes
No secondary outcomes reported