Portal Vein, Thrombectomy, Thrombosis
Conditions
Brief summary
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).
Detailed description
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).
Interventions
DEVICEInari Triever Aspiration Catheter
Inari Triever Aspiration Catheter for portomesenteric venous thrombosis
Sponsors
Inari Medical
University of Maryland, Baltimore
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years, * PMVT diagnosed on cross-sectional imaging such as contrast-enhanced CT or MRI abdomen * Symptomatic PMVT (persistent symptom, worsening abdominal pain after initiation of anticoagulation, development of peritonitis, complication of portal hypertension in cirrhosis (variceal bleeding or worsening ascites), and poor surgical candidates * Speaks and understands English language
Exclusion criteria
* Age \< 18 years * no PMVT diagnosed on cross-sectional imaging such as contrast-enhanced CT or MRI abdomen * Malignant PMVT * chronic PMVT including presence of cavernoma and network of prominent collateral vessels in porta hepatis on cross-sectional imaging. * asymptomatic PMVT * life expectancy \< 6 months * Does not speak or understand English language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Time of intervention | Uncomplicated transjugular access to the portal vein combined with uncomplicated implementation of the Inari Triever Aspiration Catheter for mechanical thrombectomy. |
| Clinical Success | 1 week, 1 month and 3 months post intervention | Partial or complete resolution of patient's primary presenting symptoms, including ascites, gastrointestinal bleeding, and postprandial pain. |
| Primary Patency | 3 months post intervention | Uninterrupted patency without any repeat intervention. |
| Intermediate functional success | Time of intervention | Recanalization of the PMVT with re-established any level of hepatopetal flow in PMV system following Inari Flow Triever-assisted mechnical thrombectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Patency | 3 months post intervention | Uninterrupted patency in patient who underwent re-intervention due to recurrent thrombosis. |
| Duration of hospitalization | 3 months post intervention | Time from admission to hospital to the time of discharge from hospital. |
| Duration of ICU days | 3 months post intervention | Time from transfer to ICU to discharge/transfer from ICU |
| Blood loss during intervention | At time of intervention | Total amount of blood loss (mL) during the intervention |
| Transfusion | 3 months post intervention | Total amount of PRBC given post-intervention and number of patient's requiring transfusion post-intervention. |
| Major and minor complications | 1 week, 1 month, and 3 months post intervention | Society of Interventional Radiology major and minor complication will be used to categorize the complications. |
| 30-day mortality | 30 days post intervention | Death occurring within 30 days |
Outcome results
None listed