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

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: Recruiting
• Conditions: May-Thurner Syndrome; Iliac Venous Compression
• Intervention / Treatment: Procedure: non-contrast enhanced abdomen and pelvis MRI

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noelle Bodkin; Phone Number: 774-441-8442.; Email: noelle.bodkin@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • University of Massachusetts
      • Contact: Noelle Bodkin; Phone Number: 774-441-8442; Email: noelle.bodkin@umassmed.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Flow Volume	Flow volume in the iliac veins calculated based on the 2D and 4D flow MRI obtained.	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	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow Velocity Profile	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)	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	Chronic venous quality-of-life questionnaire (CIVIQ-20 Global Index)	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	Index Procedure
Target vessel revascularization	Determination of target vessel revascularization	30 days, 6 months, 12 months, 24 months, 36 months
Target lesion revascularization	Determination of target lesion revascularization	30 days, 6 months, 12 months, 24 months, 36 months
Major adverse events	Identification of any major adverse events experienced	6 Months, 12 Months, 24 Months, 36 Months
Clinical-etiologic-anatomic-pathophysiologic clinical score (CEAP)	CEAP score assessment	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.	24 Months, 36 Months
Stent integrity	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

• Sponsor: Ningcheng Peter Li
• Investigators: Principal Investigator: Ningcheng Li, MD, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: May-Thurner Syndrome; Iliac Venous Disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Peripheral Vascular Diseases; Vascular Malformations; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; May-Thurner Syndrome
• Other Study ID 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