ThrombosisNCT06318754
Large-Bore Mechanic Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis
An observational study of Thrombosis and Thrombectomy, run by University of Maryland, Baltimore.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Thrombectomy, Portal Vein
- What is being tested?
- Inari Triever Aspiration Catheter
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Mar 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
Read the 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).
- Conditions
- Thrombosis, Thrombectomy, Portal Vein
- Being tested
- Inari Triever Aspiration Catheter
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inari Triever Aspiration CatheterDevice
Inari Triever Aspiration Catheter for portomesenteric venous thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Uncomplicated transjugular access to the portal vein combined with uncomplicated implementation of the Inari Triever Aspiration Catheter for mechanical thrombectomy.
Measured: Time of intervention
Clinical Success
Partial or complete resolution of patient's primary presenting symptoms, including ascites, gastrointestinal bleeding, and postprandial pain.
Measured: 1 week, 1 month and 3 months post intervention
Primary Patency
Uninterrupted patency without any repeat intervention.
Measured: 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.
Measured: Time of intervention
Secondary outcomes (7)
Secondary Patency
Uninterrupted patency in patient who underwent re-intervention due to recurrent thrombosis.
Measured: 3 months post intervention
Duration of hospitalization
Time from admission to hospital to the time of discharge from hospital.
Measured: 3 months post intervention
Duration of ICU days
Time from transfer to ICU to discharge/transfer from ICU
Measured: 3 months post intervention
Blood loss during intervention
Total amount of blood loss (mL) during the intervention
Measured: At time of intervention
Transfusion
Total amount of PRBC given post-intervention and number of patient's requiring transfusion post-intervention.
Measured: 3 months post intervention
Major and minor complications
Society of Interventional Radiology major and minor complication will be used to categorize the complications.
Measured: 1 week, 1 month, and 3 months post intervention
30-day mortality
Death occurring within 30 days
Measured: 30 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study startMar 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionMar 2027 (estimated)
Why it stopped: PI is leaving UMB institution. IRB approval was never obtained and the study was never open.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Inari Medical
- Responsible party
- Principal investigator, Adam Fang, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318754
- Sponsor's protocol ID
- HP-00104241
- Status last verified
- Nov 2024
- First submitted
- 23 Feb 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large-bore Mechanical Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis
- ClinicalTrials.gov ID
- NCT06318754
- Acronym / sponsor ID
- HP-00104241
- Conditions
- Thrombosis, Thrombectomy, Portal Vein
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI is leaving UMB institution. IRB approval was never obtained and the study was never open.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Inari Medical
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inari Triever Aspiration CatheterInari Triever Aspiration Catheter for portomesenteric venous thrombosis | Device | – |
Primary outcome
Technical Success
Time frame: Time of intervention
Uncomplicated transjugular access to the portal vein combined with uncomplicated implementation of the Inari Triever Aspiration Catheter for mechanical thrombectomy.
Clinical Success
Time frame: 1 week, 1 month and 3 months post intervention
Partial or complete resolution of patient's primary presenting symptoms, including ascites, gastrointestinal bleeding, and postprandial pain.
Primary Patency
Time frame: 3 months post intervention
Uninterrupted patency without any repeat intervention.
Intermediate functional success
Time frame: Time of intervention
Recanalization of the PMVT with re-established any level of hepatopetal flow in PMV system following Inari Flow Triever-assisted mechnical thrombectomy.
7 secondary outcomes
Secondary Patency
Time frame: 3 months post intervention
Duration of hospitalization
Time frame: 3 months post intervention
Duration of ICU days
Time frame: 3 months post intervention
Blood loss during intervention
Time frame: At time of intervention
Transfusion
Time frame: 3 months post intervention
Major and minor complications
Time frame: 1 week, 1 month, and 3 months post intervention
30-day mortality
Time frame: 30 days post intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis and Thrombectomy, run by University of Maryland, Baltimore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Time of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.