Thrombosis Clinical Trial
Official title:
Large-bore Mechanical Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis
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 |
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).
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | Inari Medical |
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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