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

NCT06888024 — Not applicable, Recruiting, 15 participants, Ningcheng Peter Li

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Registry	NCT06888024
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, single group, masking: none, basic science
Enrollment	15 (Estimated)
Sponsor	Ningcheng Peter Li (Other)
Conditions	May-Thurner Syndrome, Iliac Venous Compression
Interventions	non-contrast enhanced abdomen and pelvis MRI (Procedure)
Dates	start 2025-04-01, primary completion 2029-01-01 (estimated), completion 2029-04-01 (estimated), first posted 2025-03-21, last updated 2026-09-24
Locations	1 site in United States

-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.

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients with no imaging evidence of iliac venous disease	Experimental	Procedure: non-contrast enhanced abdomen and pelvis MRI	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
Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome).	Experimental	Procedure: non-contrast enhanced abdomen and pelvis MRI	Patients 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 MRI	Patients with a history of iliac stent placement to undergo 2D and 4D flow MRI without contrast administration

non-contrast enhanced abdomen and pelvis MRI (Procedure): non-contrast enhanced abdomen and pelvis MRI

+Outcome measures

Primary outcomes

Flow Volume [At Enrollment]: Flow volume in the iliac veins calculated based on the 2D and 4D flow MRI obtained.
12-month primary patency rate [12 Months]: Freedom from occlusion of the stented segment; Freedom from restenosis >=50%; and Freedom from clinically-driven target lesion revascularization

Secondary outcomes

Flow Velocity Profile [At Enrollment]: Flow velocity profile in the iliac veins calculated based on the 2D and 4D flow MRI obtained.
Quality-of-life measure: Venous clinical severity score (VCSS) [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.
Quality-of-life measures [Baseline to 6 Months, 12 Months, 24 Months, 36 Months]: Chronic venous quality-of-life questionnaire (CIVIQ-20 Global Index)
Technical success [Index Procedure]: Successful delivery and deployment of the stent and removal of the delivery system during the index procedure
Target vessel revascularization [30 days, 6 months, 12 months, 24 months, 36 months]: Determination of target vessel revascularization
Target lesion revascularization [30 days, 6 months, 12 months, 24 months, 36 months]: Determination of target lesion revascularization
Major adverse events [6 Months, 12 Months, 24 Months, 36 Months]: Identification of any major adverse events experienced
Clinical-etiologic-anatomic-pathophysiologic clinical score (CEAP) [Baseline to 6 Months, 12 Months, 24 Months, 36 Months]: CEAP score assessment
Primary Patency [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.
Stent integrity [30 Days, 12 Months, 24 Months, 36 Months]: Determination of integrity of the stent via scheduled visit-based evaluable imaging and unscheduled imaging

+Eligibility

Sex: All, ages: 18 Years to 89 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
University of Massachusetts	Worcester, Massachusetts	United States	Recruiting

+Investigators

Ningcheng Li, MD, Principal investigator, UMass Chan Medical School

My Notes

Public

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