May-Thurner SyndromeNCT06888024
Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI
A study testing non-contrast enhanced abdomen and pelvis MRI in people with May-Thurner Syndrome and Iliac Venous Compression, run by Ningcheng Peter Li at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- May-Thurner Syndrome, Iliac Venous Compression
- What is being tested?
- non-contrast enhanced abdomen and pelvis MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 21Show fewer
- Arm 2: Inclusion Criteria:
- Clinical symptoms or imaging findings compatible with left iliac vein compression syndrome
- 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
- Contraindication to MRI examination
- Prisoners
- Subjects ≤ 18 years of age
- Pregnant women
- Adults unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts
Worcester, Massachusetts, 01655
Noelle Bodkin, 774-441-8442, noelle.bodkin@umassmed.edu
About this study
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.
- Conditions
- May-Thurner Syndrome, Iliac Venous Compression
- Being tested
- non-contrast enhanced abdomen and pelvis MRI
- Keywords
- May-Thurner Syndrome, Iliac Venous Disease
- Medical subject headings
- May-Thurner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-contrast enhanced abdomen and pelvis MRIProcedure or surgery
non-contrast enhanced abdomen and pelvis MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients with no imaging evidence of iliac venous disease | Experimental | 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 Receives: Procedure: non-contrast enhanced abdomen and pelvis MRI |
| Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome). | Experimental | Patients with prior imaging evidence of left common iliac vein compression syndrome to undergo 2D and 4D flow MRI without contrast administration Receives: Procedure: non-contrast enhanced abdomen and pelvis MRI |
| Patients status post iliac stent placement | Experimental | Patients with a history of iliac stent placement to undergo 2D and 4D flow MRI without contrast administration Receives: Procedure: non-contrast enhanced abdomen and pelvis MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Volume
Flow volume in the iliac veins calculated based on the 2D and 4D flow MRI obtained.
Measured: At Enrollment
12-month primary patency rate
Freedom from occlusion of the stented segment; Freedom from restenosis >=50%; and Freedom from clinically-driven target lesion revascularization
Measured: 12 Months
Secondary outcomes (10)
Flow Velocity Profile
Flow velocity profile in the iliac veins calculated based on the 2D and 4D flow MRI obtained.
Measured: At Enrollment
Quality-of-life measure: Venous clinical severity score (VCSS)
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.
Measured: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Quality-of-life measures
Chronic venous quality-of-life questionnaire (CIVIQ-20 Global Index)
Measured: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Technical success
Successful delivery and deployment of the stent and removal of the delivery system during the index procedure
Measured: Index Procedure
Target vessel revascularization
Determination of target vessel revascularization
Measured: 30 days, 6 months, 12 months, 24 months, 36 months
Target lesion revascularization
Determination of target lesion revascularization
Measured: 30 days, 6 months, 12 months, 24 months, 36 months
Major adverse events
Identification of any major adverse events experienced
Measured: 6 Months, 12 Months, 24 Months, 36 Months
Clinical-etiologic-anatomic-pathophysiologic clinical score (CEAP)
CEAP score assessment
Measured: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Primary Patency
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.
Measured: 24 Months, 36 Months
Stent integrity
Determination of integrity of the stent via scheduled visit-based evaluable imaging and unscheduled imaging
Measured: 30 Days, 12 Months, 24 Months, 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Apr 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for May-Thurner SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningcheng Peter Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ningcheng Peter Li, University of Massachusetts, Worcester
- Investigators
- Ningcheng Li, MD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888024
- Sponsor's protocol ID
- STUDY00002051
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI
- ClinicalTrials.gov ID
- NCT06888024
- Acronym / sponsor ID
- STUDY00002051
- Conditions
- May-Thurner Syndrome, Iliac Venous Compression
- Keywords
- May-Thurner Syndrome, Iliac Venous Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ningcheng Peter LiUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 21 Mar 2025 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with no imaging evidence of iliac venous disease | Experimental | Procedure: non-contrast enhanced abdomen and pelvis MRIHealthy 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 |
| Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome). | Experimental | Procedure: non-contrast enhanced abdomen and pelvis MRIPatients with prior imaging evidence of left common iliac vein compression syndrome to undergo 2D and 4D flow MRI without contrast administration |
| Patients status post iliac stent placement | Experimental | Procedure: non-contrast enhanced abdomen and pelvis MRIPatients with a history of iliac stent placement to undergo 2D and 4D flow MRI without contrast administration |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- History of pelvic or iliac venous disease or intervention
- Contraindication to MRI examination
- Prisoners
- Subjects ≤ 18 years of age
- Pregnant women
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 |
|---|---|---|
| non-contrast enhanced abdomen and pelvis MRInon-contrast enhanced abdomen and pelvis MRI | Procedure or surgery | Patients status post iliac stent placement, Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome)., Patients with no imaging evidence of iliac venous disease |
Primary outcome
Flow Volume
Time frame: At Enrollment
Flow volume in the iliac veins calculated based on the 2D and 4D flow MRI obtained.
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
10 secondary outcomes
Flow Velocity Profile
Time frame: At Enrollment
Quality-of-life measure: Venous clinical severity score (VCSS)
Time frame: 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
Technical success
Time frame: Index Procedure
Target vessel revascularization
Time frame: 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
Major adverse events
Time frame: 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
Primary Patency
Time frame: 24 Months, 36 Months
Stent integrity
Time frame: 30 Days, 12 Months, 24 Months, 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
Ningcheng Li, MD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-contrast enhanced abdomen and pelvis MRI in people with May-Thurner Syndrome and Iliac Venous Compression, run by Ningcheng Peter Li at 1 site in United States.
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 0 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noelle Bodkin (774-441-8442., noelle.bodkin@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow Volume (time frame: At Enrollment). The study lists 2 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 24 Sep 2026.