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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06318754
Other study ID # HP-00104241
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date June 2026

Study information

Verified date March 2024
Source University of Maryland, Baltimore
Contact Adam Fang, MD
Phone (410) 328-8162
Email adam.fang@umm.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date June 2026
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Inari Triever Aspiration Catheter
Inari Triever Aspiration Catheter for portomesenteric venous thrombosis

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Maryland, Baltimore Inari Medical

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Primary Patency Uninterrupted patency without any repeat intervention. 3 months post intervention
Primary 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 Secondary Patency Uninterrupted patency in patient who underwent re-intervention due to recurrent thrombosis. 3 months post intervention
Secondary Duration of hospitalization Time from admission to hospital to the time of discharge from hospital. 3 months post intervention
Secondary Duration of ICU days Time from transfer to ICU to discharge/transfer from ICU 3 months post intervention
Secondary Blood loss during intervention Total amount of blood loss (mL) during the intervention At time of intervention
Secondary Transfusion Total amount of PRBC given post-intervention and number of patient's requiring transfusion post-intervention. 3 months post intervention
Secondary 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
Secondary 30-day mortality Death occurring within 30 days 30 days post intervention
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