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| Name | Class |
|---|---|
| Vorpal Technologies | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Analysis Population | All subjects who the survey device entered their vasculature. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClotTriever® Thrombectomy System | Device | ClotTriever® Thrombectomy System use for treatment of patients with deep vein thrombosis with acute severe symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Adverse Events | 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]. | Through 30 days post index procedure. |
| Technical Success | Thrombus residual volume assessed by the the treating physician using pre- and post-procedure venography to evaluate the success of thrombus removal. | During the index procedure |
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This is an all-comers survey of all patients treated with ClotTriever® Thrombectomy System in Japan.
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All patients with deep vein thrombosis with acute severe symptoms (excluding postthrombotic syndrome) for whom the ClotTriever® Thrombectomy System was used. Patients will be enrolled until at least 100 subjects complete the follow-up period through 6 months.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba University Hospital | Chuo | Chiba | 260-8677 | Japan | ||
| Ota Memorial Hospital |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Ōta |
| Gunma |
| 373-8585 |
| Japan |
| St. Marianna University Hospital | Kawasaki | Kanagawa | 216-8511 | Japan |
| National Cerebral and Cardiovascular Center | Suita | Osaka | 564-8565 | Japan |
| Asahikawa Medical Hospital | Asahikawa | 078-8510 | Japan |
| Asahi General Hospital | Chiba | 289-2511 | Japan |
| Nozaki Tokushukai Hospital | Daitō | 574-0074 | Japan |
| Shonan Kamakura | Kanagawa | 247-8533 | Japan |
| Kyoto Katsura Hospital | Kyoto | 615-8256 | Japan |
| Nara City Hospital | Nara | 630-8305 | Japan |
| Osaka Police Hospital | Osaka | 543-0042 | Japan |
| Mitsui Memorial Hospital | Tokyo | 101-8643 | Japan |
| Keio University | Tokyo | 160-8582 | Japan |
| Mie University | Tsu | 514-0102 | Japan |