Clinical trial NCT06888024: Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI
Official title: Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: May-Thurner Syndrome
Iliac Venous Compression
Keywords: May-Thurner Syndrome
Iliac Venous Disease
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


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

Primary outcomes:
measure: Flow Volume
timeFrame: At Enrollment
measure: 12-month primary patency rate
timeFrame: 12 Months
Secondary outcomes:
measure: Flow Velocity Profile
timeFrame: At Enrollment
measure: Quality-of-life measure: Venous clinical severity score (VCSS)
timeFrame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
measure: Quality-of-life measures
timeFrame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
measure: Technical success
timeFrame: Index Procedure
measure: Target vessel revascularization
timeFrame: 30 days, 6 months, 12 months, 24 months, 36 months
measure: Target lesion revascularization
timeFrame: 30 days, 6 months, 12 months, 24 months, 36 months
measure: Major adverse events
timeFrame: 6 Months, 12 Months, 24 Months, 36 Months
measure: Clinical-etiologic-anatomic-pathophysiologic clinical score (CEAP)
timeFrame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
measure: Primary Patency
timeFrame: 24 Months, 36 Months
measure: Stent integrity
timeFrame: 30 Days, 12 Months, 24 Months, 36 Months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: Ningcheng Li, MD
role: PRINCIPAL_INVESTIGATOR
References: