NCT06394739招募中不适用
RevCore for In Stent Thrombosis (REVIT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 30
- 主要终点
- Evidence of successful stent recanalization
研究概览
简要总结
The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.
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
- •Patients with stent age > 6 weeks
- •Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein
- •RevCore Thrombectomy Catheter must enter vasculature
- •Willing and able to provide informed consent
排除标准
- •Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel
- •Stents not wall apposed
- •Stents compressed to <10mm
- •Bilateral in-stent thrombosis
- •Congenital anatomic anomalies of the iliac veins
- •Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
- •Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
- •Chronic non-ambulatory status
- •Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period
- •Inability to secure venous access
- •Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
- •Current participation in another investigational drug or device treatment study
结局指标
主要结局
Evidence of successful stent recanalization
时间窗: Immediately after the RevCore thrombectomy procedure for in-stent thrombosis
Defined as patency ≥50% luminal diameter utilizing intravascular ultrasound (IVUS)
次要结局
未报告次要终点
研究者
研究点 (30)
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