Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Flow Volume
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Arm 1: Inclusion Criteria:
- •No self-reported history of pelvic or iliac venous disease or associated symptoms
排除标准
- •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
研究组 & 干预措施
Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome).
Patients with prior imaging evidence of left common iliac vein compression syndrome to undergo 2D and 4D flow MRI without contrast administration
干预措施: non-contrast enhanced abdomen and pelvis MRI (Procedure)
Patients status post iliac stent placement
Patients with a history of iliac stent placement to undergo 2D and 4D flow MRI without contrast administration
干预措施: non-contrast enhanced abdomen and pelvis MRI (Procedure)
Patients with no imaging evidence of iliac venous disease
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
干预措施: non-contrast enhanced abdomen and pelvis MRI (Procedure)
结局指标
主要结局
Flow Volume
时间窗: At Enrollment
Flow volume in the iliac veins calculated based on the 2D and 4D flow MRI obtained.
12-month primary patency rate
时间窗: 12 Months
Freedom from occlusion of the stented segment; Freedom from restenosis \>=50%; and Freedom from clinically-driven target lesion revascularization
次要结局
- Quality-of-life measures(Baseline to 6 Months, 12 Months, 24 Months, 36 Months)
- Flow Velocity Profile(At Enrollment)
- Quality-of-life measure: Venous clinical severity score (VCSS)(Baseline to 6 Months, 12 Months, 24 Months, 36 Months)
- Technical success(Index Procedure)
- Target vessel revascularization(30 days, 6 months, 12 months, 24 months, 36 months)
- Target lesion revascularization(30 days, 6 months, 12 months, 24 months, 36 months)
- Major adverse events(6 Months, 12 Months, 24 Months, 36 Months)
- Clinical-etiologic-anatomic-pathophysiologic clinical score (CEAP)(Baseline to 6 Months, 12 Months, 24 Months, 36 Months)
- Primary Patency(24 Months, 36 Months)
- Stent integrity(30 Days, 12 Months, 24 Months, 36 Months)
研究者
Ningcheng Peter Li
Principal Investigator
University of Massachusetts, Worcester