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

Large-bore Mechanical Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis

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).

Study Overview

• Status: Withdrawn
• Conditions: Thrombosis; Thrombectomy; Portal Vein
• Intervention / Treatment: Device: Inari Triever Aspiration Catheter

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 Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing a large-bore thrombectomy procedure for PMVT in the Division of Vascular and Interventional Radiology (VIR) at University of Maryland Medical Center.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Inari Medical

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: HP-00104241

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes