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

NCT06318754 | Withdrawn FDA Device

• 1 other identifier: HP-00104241
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Thrombosis; Thrombectomy; Portal Vein

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Secondary Patency

  3 months post intervention

• Duration of hospitalization

  3 months post intervention

• Duration of ICU days

  3 months post intervention

• Blood loss during intervention

  At time of intervention

• Transfusion

  3 months post intervention

Interventions

Inari Triever Aspiration Catheter DEVICE

Inari Triever Aspiration Catheter for portomesenteric venous thrombosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Inari Medical: collaborator

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Diagnostic Radiology and Nuclear Medicine

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 19, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 14, 2025

Record last verified: 2024-11