ClotTriever Outcomes (CLOUT) Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 499
- 试验地点
- 43
- 主要终点
- Primary Safety Endpoint: Proportion Participants With Major Adverse Events
研究概览
简要总结
Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.
详细描述
The CLOUT Registry is a prospective, multi-center, observational registry of subjects with proximal lower extremity DVT treated with the ClotTriever Thrombectomy System. The Registry will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through 2 years of follow-up.
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
- •Proximal lower extremity DVT involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination.
- •Willing and able to provide informed consent.
排除标准
- •Prior venous stent in the target venous segment
- •IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
- •IVC filter in place at the time of the planned index procedure
- •Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
- •Life expectancy less than 1 year
- •Chronic non-ambulatory status
- •Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period
- •Unavailability of a lower extremity venous access site
结局指标
主要结局
Primary Safety Endpoint: Proportion Participants With Major Adverse Events
时间窗: 30 days
The primary safety endpoint is the proportion of participants with Major Adverse Events (MAE). MAEs are defined as a composite endpoint triggered when any of four categories of events occurred through 30 days after the index procedure, as observed in the Primary Safety Cohort (the composite endpoints were not observed for the Full Analysis Population: * All-cause mortality * Major bleeding * New symptomatic pulmonary embolism (PE) documented by computed tomography pulmonary angiography (CTPA) * Rethrombosis of a target vessel segment (TVS)
次要结局
- Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus(Index Procedure (approximately 0.5 hours on day 0))