Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI

Ningcheng Peter Li15 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

May-Thurner Syndrome Iliac Venous Compression

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Flow Volume

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

Time frame: 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

Time frame: 12 Months

Secondary Outcomes

Flow Velocity Profile

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

Time frame: At Enrollment

Quality-of-life measure: Venous clinical severity score (VCSS)

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.

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

Quality-of-life measures

Chronic venous quality-of-life questionnaire (CIVIQ-20 Global Index)

Time frame: 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

Time frame: Index Procedure

Target vessel revascularization

Determination of target vessel revascularization

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

Target lesion revascularization

Determination of target lesion revascularization

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

Major adverse events

Identification of any major adverse events experienced

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

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

CEAP score assessment

Time frame: 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.

Time frame: 24 Months, 36 Months

Stent integrity

Determination of integrity of the stent via scheduled visit-based evaluable imaging and unscheduled imaging

Time frame: 30 Days, 12 Months, 24 Months, 36 Months

Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts