Deep Vein Thrombosis
Conditions
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.
Interventions
ClotTriever® Thrombectomy System use for treatment of patients with deep vein thrombosis with acute severe symptoms.
Sponsors
Study design
Eligibility
Inclusion criteria
This is an all-comers survey of all patients treated with ClotTriever® Thrombectomy System in Japan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events | 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 | 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. |
Countries
Japan