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

ConditionsMay-Thurner SyndromeIliac Venous Compression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorNingcheng Peter Li

About this trial

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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

History of pelvic or iliac venous disease or intervention

Contraindication to MRI examination

Prisoners

Subjects ≤ 18 years of age

Trial design

Design model

Single group

Treatments tested in this trial

  • non-contrast enhanced abdomen and pelvis MRI

    Procedure/Surgery

    non-contrast enhanced abdomen and pelvis MRI

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: Patients with no imaging evidence of iliac venous diseaseExperimental treatment 1 intervention
Group B: Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome).Experimental treatment 1 intervention
Group C: Patients status post iliac stent placementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Flow Volume

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

Time frame
At Enrollment
2

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

1

Flow Velocity Profile

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

Time frame
At Enrollment
2

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
3

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
4

Technical success

Successful delivery and deployment of the stent and removal of the delivery system during the index procedure

Time frame
Index Procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ningcheng Peter Li

Lead sponsor

University of Massachusetts, Worcester

Sponsor institution

Source ClinicalTrials.gov
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