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NCT Number: NCT06888024

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.

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Key information

Conditions

May-Thurner Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Iliac Venous Compression Peripheral Vascular Diseases Vascular Diseases Vascular Malformations

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location status: Recruiting

Location contact

Noelle Bodkin

CONTACT

[email protected]

774-441-8442

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-contrast enhanced abdomen and pelvis MRI

Procedure

non-contrast enhanced abdomen and pelvis MRI

Primary outcomes

  1. Flow Volume

    Time frame: At Enrollment

    Flow volume in the iliac veins calculated based on the 2D and 4D flow MRI obtained.

  2. 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

Secondary outcomes

  1. Flow Velocity Profile

    Time frame: At Enrollment

    Flow velocity profile in the iliac veins calculated based on the 2D and 4D flow MRI obtained.

  2. 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.

  3. 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)

  4. Technical success

    Time frame: Index Procedure

    Successful delivery and deployment of the stent and removal of the delivery system during the index procedure

  5. Target vessel revascularization

    Time frame: 30 days, 6 months, 12 months, 24 months, 36 months

    Determination of target vessel revascularization

  6. Target lesion revascularization

    Time frame: 30 days, 6 months, 12 months, 24 months, 36 months

    Determination of target lesion revascularization

  7. Major adverse events

    Time frame: 6 Months, 12 Months, 24 Months, 36 Months

    Identification of any major adverse events experienced

  8. Clinical-etiologic-anatomic-pathophysiologic clinical score (CEAP)

    Time frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months

    CEAP score assessment

  9. 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.

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Noelle Bodkin

CONTACT

[email protected]

774-441-8442.

Sponsors and collaborators

Lead sponsor

Ningcheng Peter Li

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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