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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with no imaging evidence of iliac venous disease | Experimental | 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 |
|
| Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome). | Experimental | Patients with prior imaging evidence of left common iliac vein compression syndrome to undergo 2D and 4D flow MRI without contrast administration |
|
| Patients status post iliac stent placement | Experimental | Patients with a history of iliac stent placement to undergo 2D and 4D flow MRI without contrast administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-contrast enhanced abdomen and pelvis MRI | Procedure | non-contrast enhanced abdomen and pelvis MRI |
|
| 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 |
| 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) |
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Arm 1: Inclusion Criteria:
• No self-reported history of pelvic or iliac venous disease or associated symptoms
Exclusion Criteria:
Arm 2: Inclusion Criteria:
• Clinical symptoms or imaging findings compatible with left iliac vein compression syndrome
Exclusion Criteria:
Arm 3: Inclusion Criteria:
• History of left iliac vein stent placement
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noelle Bodkin | Contact | 774-441-8442. | noelle.bodkin@umassmed.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ningcheng Li, MD | UMass Chan Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts | Recruiting | Worcester | Massachusetts | 01655 | United States |
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| ID | Term |
|---|---|
| D062108 | May-Thurner Syndrome |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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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 |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |