Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI

September 18, 2025 updated by: Ningcheng Peter Li

The purpose of the study is to quantitatively characterize the flow in the pelvic venous structures using 2D and 4D flow MRI with the objective of establishing physiologic and pathologic parameters for downstream computational fluid dynamics analysis.

Arm 1: To establish the baseline flow characteristics of the iliac veins in patients with no imaging evidence of iliac venous disease.

Arm 2: To assess the flow characteristics of the iliac veins in patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome).

Arm 3: To assess the flow characteristics of the iliac veins in patients status post iliac stent placement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Arm 1: Inclusion Criteria:

• No self-reported history of pelvic or iliac venous disease or associated symptoms

Exclusion Criteria:

  • History of pelvic or iliac venous disease or intervention
  • Contraindication to MRI examination
  • Prisoners
  • Subjects ≤ 18 years of age
  • Pregnant women
  • Adults unable to provide informed consent

Arm 2: Inclusion Criteria:

• Clinical symptoms or imaging findings compatible with left iliac vein compression syndrome

Exclusion Criteria:

  • History of pelvic or iliac venous intervention
  • Contraindication to MRI examination
  • Prisoners
  • Subjects ≤ 18 years of age
  • Pregnant women
  • Adults unable to provide informed consent

Arm 3: Inclusion Criteria:

• History of left iliac vein stent placement

Exclusion Criteria:

  • Contraindication to MRI examination
  • Prisoners
  • Subjects ≤ 18 years of age
  • Pregnant women
  • Adults unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with no imaging evidence of iliac venous disease
Healthy volunteers with no self-reported history or prior imaging evidence of pelvic venous disease or associated symptoms to undergo 2D and 4D flow MRI without contrast administration
Procedure: non-contrast enhanced abdomen and pelvis MRI
non-contrast enhanced abdomen and pelvis MRI
Experimental: Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome).
Patients with prior imaging evidence of left common iliac vein compression syndrome to undergo 2D and 4D flow MRI without contrast administration
Procedure: non-contrast enhanced abdomen and pelvis MRI
non-contrast enhanced abdomen and pelvis MRI
Experimental: Patients status post iliac stent placement
Patients with a history of iliac stent placement to undergo 2D and 4D flow MRI without contrast administration
Procedure: non-contrast enhanced abdomen and pelvis MRI
non-contrast enhanced abdomen and pelvis MRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flow Volume
Time Frame: At Enrollment
Flow volume in the iliac veins calculated based on the 2D and 4D flow MRI obtained.
At Enrollment
12-month primary patency rate
Time Frame: 12 Months
Freedom from occlusion of the stented segment; Freedom from restenosis >=50%; and Freedom from clinically-driven target lesion revascularization
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Flow Velocity Profile
Time Frame: At Enrollment
Flow velocity profile in the iliac veins calculated based on the 2D and 4D flow MRI obtained.
At Enrollment
Quality-of-life measure: Venous clinical severity score (VCSS)
Time Frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Venous clinical severity scale (VCSS) is used to assess chronic venous disease (CVD) severity through clinical symptoms and signs. Ten areas are scored on a range from 0 (none) to 3 (severe), depending on the presence and severity of symptoms, signs, and the use of compression therapy. The scores for each of the ten items are then combined to calculate the total VCSS score with a higher score indicating more severe disease.
Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Quality-of-life measures
Time Frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Chronic venous quality-of-life questionnaire (CIVIQ-20 Global Index)
Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Technical success
Time Frame: Index Procedure
Successful delivery and deployment of the stent and removal of the delivery system during the index procedure
Index Procedure
Target vessel revascularization
Time Frame: 30 days, 6 months, 12 months, 24 months, 36 months
Determination of target vessel revascularization
30 days, 6 months, 12 months, 24 months, 36 months
Target lesion revascularization
Time Frame: 30 days, 6 months, 12 months, 24 months, 36 months
Determination of target lesion revascularization
30 days, 6 months, 12 months, 24 months, 36 months
Major adverse events
Time Frame: 6 Months, 12 Months, 24 Months, 36 Months
Identification of any major adverse events experienced
6 Months, 12 Months, 24 Months, 36 Months
Clinical-etiologic-anatomic-pathophysiologic clinical score (CEAP)
Time Frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
CEAP score assessment
Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Primary Patency
Time Frame: 24 Months, 36 Months
Freedom from occlusion of the stented segment of the target lesion; Freedom from restenosis ≥50% of the stented segment of the target lesion; Freedom from clinically driven target lesion revascularization.
24 Months, 36 Months
Stent integrity
Time Frame: 30 Days, 12 Months, 24 Months, 36 Months
Determination of integrity of the stent via scheduled visit-based evaluable imaging and unscheduled imaging
30 Days, 12 Months, 24 Months, 36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ningcheng Peter Li

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ningcheng Li, MD, UMass Chan Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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