Iliac Venous Compression, May-Thurner Syndrome
Conditions
Keywords
May-Thurner Syndrome, Iliac Venous Disease
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.
Interventions
PROCEDUREnon-contrast enhanced abdomen and pelvis MRI
non-contrast enhanced abdomen and pelvis MRI
Sponsors
Ningcheng Peter Li
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Flow Velocity Profile | At Enrollment | Flow velocity profile in the iliac veins calculated based on the 2D and 4D flow MRI obtained. |
| 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 |
| Major adverse events | 6 Months, 12 Months, 24 Months, 36 Months | Identification of any major adverse events experienced |
| 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. |
Countries
United States
Contacts
Primary ContactNoelle Bodkin
Outcome results
None listed