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PI is leaving UMB institution. IRB approval was never obtained and the study was never open.
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| Name | Class |
|---|---|
| Inari Medical | INDUSTRY |
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A single site study evaluating the safety, feasibility, and effectiveness of percutaneous large-bore mechanical thrombectomy using the Inari Triever Aspiration Catheter for the treatment of portomesenteric vein thrombosis (PMVT).
This is a single center, prospective, investigator-initiated observational study of adults undergoing mechanical thrombectomy as part of clinical care for portomesenteric vein thrombosis (PMVT).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inari Triever Aspiration Catheter | Device | Inari Triever Aspiration Catheter for portomesenteric venous thrombosis |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Uncomplicated transjugular access to the portal vein combined with uncomplicated implementation of the Inari Triever Aspiration Catheter for mechanical thrombectomy. | Time of intervention |
| Clinical Success | Partial or complete resolution of patient's primary presenting symptoms, including ascites, gastrointestinal bleeding, and postprandial pain. | 1 week, 1 month and 3 months post intervention |
| Primary Patency | Uninterrupted patency without any repeat intervention. | 3 months post intervention |
| Intermediate functional success | Recanalization of the PMVT with re-established any level of hepatopetal flow in PMV system following Inari Flow Triever-assisted mechnical thrombectomy. | Time of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Patency | Uninterrupted patency in patient who underwent re-intervention due to recurrent thrombosis. | 3 months post intervention |
| Duration of hospitalization | Time from admission to hospital to the time of discharge from hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults undergoing a large-bore thrombectomy procedure for PMVT in the Division of Vascular and Interventional Radiology (VIR) at University of Maryland Medical Center.
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 3 months post intervention |
| Duration of ICU days | Time from transfer to ICU to discharge/transfer from ICU | 3 months post intervention |
| Blood loss during intervention | Total amount of blood loss (mL) during the intervention | At time of intervention |
| Transfusion | Total amount of PRBC given post-intervention and number of patient's requiring transfusion post-intervention. | 3 months post intervention |
| Major and minor complications | Society of Interventional Radiology major and minor complication will be used to categorize the complications. | 1 week, 1 month, and 3 months post intervention |
| 30-day mortality | Death occurring within 30 days | 30 days post intervention |