NCT03842930已完成不适用
Embolization of the Lumbar Arteries Before EVAR: A Prospectively Randomized Trial Comparing Platinum-Fibered Microcoils (Control Arm) With the MVP® Microvascular Plug (Study Arm)
University of Leipzig2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Radiation dose for embolization of the lumbar arteries with the MVP plug or coils
研究概览
简要总结
Prospective, Randomized, Single-center Study for the Treatment of Subjects with Abdominal Aortic Aneurysm: Embolization of the Lumbar Arteries Before EVAR: A Prospectively Randomized Trial Comparing Platinum-Fibered Microcoils (control arm) with the MVP® Microvascular Plug (study arm)"
详细描述
This study is a prospective, single-center, 1:1 randomized trial to investigate the difference in radiation dose and intervention time between the embolization with FCP and MVP-Plug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject age ≥ 18
- •Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
- •Indication for the occlusion of lumbar arteries due to:
- •Subject has an abdominal aortic aneurysm and
- •At least 2 patent lumbar arteries in the diseased area
- •Subject understands the duration of the study, agrees to attend the stentgraft implantation
- •A microcatheter is successfully placed the target lumbar artery.
排除标准
- •Any surgical procedure or intervention performed within 30 days prior to or post index procedure
- •Aortic aneurysm requires treatment with alternative therapies such as operation
- •any other aortic pathology
- •major untreated cardio-pulmonary disease
- •life-expectancy of less than one year
- •expected lack of compliance (e.g. if the patient may not be willing to have several sessions and the following repair done)
- •pregnant or nursing women
- •impaired thyroid function, if not under stable treatment
- •women of child-bearing potential without highly effective contraceptive measures
- •Enrolled in another investigational drug, device or biologic study
- •Failure to successfully intubate an lumbar artery
- •Stroke or heart attack within 3 months prior to enrollment
- •Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
- •Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
- •Platelet count <100,000 mm3 or >600,000 mm3
- •Receiving dialysis or immunosuppressant therapy
- •Chronic kidney disease (serum creatinine > 2.5 mg/dL)
结局指标
主要结局
Radiation dose for embolization of the lumbar arteries with the MVP plug or coils
时间窗: through study completion, an average of 3-4 month
次要结局
- Intervention time for embolization of the lumbar arteries with the MVP plug or coils(through study completion, an average of 3-4 month)
- Success in complete occlusion of the targeted lumbar artery(through study completion, an average of 3-4 month)
研究者
Dierk Scheinert
Principal Investigator
University of Leipzig
研究点 (2)
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