Large-Bore Mechanic Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis

University of Maryland, Baltimore

Overview

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).

Study Type

OBSERVATIONAL

Conditions

Thrombosis Thrombectomy Portal Vein

Interventions

Inari Triever Aspiration CatheterDEVICE

Inari Triever Aspiration Catheter for portomesenteric venous thrombosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Technical Success

Uncomplicated transjugular access to the portal vein combined with uncomplicated implementation of the Inari Triever Aspiration Catheter for mechanical thrombectomy.

Time frame: Time of intervention

Clinical Success

Partial or complete resolution of patient's primary presenting symptoms, including ascites, gastrointestinal bleeding, and postprandial pain.

Time frame: 1 week, 1 month and 3 months post intervention

Primary Patency

Uninterrupted patency without any repeat intervention.

Time frame: 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 frame: Time of intervention

Secondary Outcomes

Secondary Patency

Uninterrupted patency in patient who underwent re-intervention due to recurrent thrombosis.

Time frame: 3 months post intervention

Duration of hospitalization

Time from admission to hospital to the time of discharge from hospital.

Time frame: 3 months post intervention

Duration of ICU days

Time from transfer to ICU to discharge/transfer from ICU

Time frame: 3 months post intervention

Blood loss during intervention

Data from ClinicalTrials.gov

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