Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: non-contrast enhanced abdomen and pelvis MRI.
- Who it may be relevant to
- Registry conditions: May-Thurner Syndrome, Iliac Venous Compression. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure non-contrast enhanced abdomen and pelvis MRI
non-contrast enhanced abdomen and pelvis MRI
Primary outcome measures
- Flow Volume [Time frame: At Enrollment]
- 12-month primary patency rate [Time frame: 12 Months]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Massachusetts — Worcester
Identifiers
NCT: NCT06888024 · STUDY00002051