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

Withdrawn

• Conditions: Thrombectomy; Portal Vein; Thrombosis

• Registration Number: NCT06318754
• Lead Sponsor: University of Maryland, Baltimore

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).

Study Timeline

• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-19
• Status Verified: 2024-11
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Study Start: 2025-03
• Primary Completion: 2026-06
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Duration of ICU days	3 months post intervention	Time from transfer to ICU to discharge/transfer from ICU
Secondary Patency	3 months post intervention	Uninterrupted patency in patient who underwent re-intervention due to recurrent thrombosis.
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
Duration of hospitalization	3 months post intervention	Time from admission to hospital to the time of discharge from hospital.