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

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06318754
• Other study ID #: HP-00104241
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Portal Vein
• Thrombectomy
• Thrombosis
• Venous Thrombosis

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