Large-bore Mechanical Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 主要终点
- Technical Success
研究概览
简要总结
A single site study evaluating the safety, feasibility, and effectiveness of percutaneous large-bore mechanical thrombectomy using the Inari Triever Aspiration Catheter for the treatment of portomesenteric vein thrombosis (PMVT).
详细描述
This is a single center, prospective, investigator-initiated observational study of adults undergoing mechanical thrombectomy as part of clinical care for portomesenteric vein thrombosis (PMVT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years,
- •PMVT diagnosed on cross-sectional imaging such as contrast-enhanced CT or MRI abdomen
- •Symptomatic PMVT (persistent symptom, worsening abdominal pain after initiation of anticoagulation, development of peritonitis, complication of portal hypertension in cirrhosis (variceal bleeding or worsening ascites), and poor surgical candidates
- •Speaks and understands English language
排除标准
- •Age < 18 years
- •no PMVT diagnosed on cross-sectional imaging such as contrast-enhanced CT or MRI abdomen
- •Malignant PMVT
- •chronic PMVT including presence of cavernoma and network of prominent collateral vessels in porta hepatis on cross-sectional imaging.
- •asymptomatic PMVT
- •life expectancy < 6 months
- •Does not speak or understand English language
结局指标
主要结局
Technical Success
时间窗: Time of intervention
Uncomplicated transjugular access to the portal vein combined with uncomplicated implementation of the Inari Triever Aspiration Catheter for mechanical thrombectomy.
Clinical Success
时间窗: 1 week, 1 month and 3 months post intervention
Partial or complete resolution of patient's primary presenting symptoms, including ascites, gastrointestinal bleeding, and postprandial pain.
Primary Patency
时间窗: 3 months post intervention
Uninterrupted patency without any repeat intervention.
Intermediate functional success
时间窗: Time of intervention
Recanalization of the PMVT with re-established any level of hepatopetal flow in PMV system following Inari Flow Triever-assisted mechnical thrombectomy.
次要结局
- Duration of ICU days(3 months post intervention)
- Secondary Patency(3 months post intervention)
- Blood loss during intervention(At time of intervention)
- Transfusion(3 months post intervention)
- Major and minor complications(1 week, 1 month, and 3 months post intervention)
- 30-day mortality(30 days post intervention)
- Duration of hospitalization(3 months post intervention)
研究者
Adam Fang
Assistant Professor of Diagnostic Radiology and Nuclear Medicine
University of Maryland, Baltimore