Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Blood Clot resolution
研究概览
简要总结
Assess the functionality of the Versus Catheter for catheter-directed thrombolysis of pulmonary blood clots, including advanced imaging assessment. An evaluation of patient outcomes from the cases included in this study will also be conducted.
详细描述
The objective of this study is to assess the functionality of the Versus™ Catheter for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients, including advanced Computerized Tomography Angiogram (CTA) imaging assessment. This study will include an evaluation of patient outcomes and physician user experience with the Versus™ Catheter among up to 10 patients meeting the criteria for enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 - 80 years, inclusive
- •Patients who present with submassive pulmonary embolism (PE)
- •Patients requiring thrombolytic intervention to the pulmonary vasculature
- •Physician decision to use the Versus™ Catheter during the treatment of the patient
排除标准
- •Concurrent treatment with thrombectomy
- •Concurrent treatment with a catheter-directed thrombolysis device that is NOT the Versus™ Catheter
- •Massive pulmonary embolism (PE)
- •Active bleeding disorder1
- •Recent cerebrovascular accident or transient ischemic attack1
- •Recent neurosurgery1
- •Recent intracranial trauma1
- •Absolute contraindication to anticoagulation1
- •BMI > 45kg/m2
- •In the opinion of the investigator, the participant is not a suitable candidate for the study
研究组 & 干预措施
Patients who receive treatment using the Versus Catheter
Patients age 18 - 80 years old who present with symptoms requiring intervention with delivery of physician-specified thrombolytics to the pulmonary vasculature, including patients who present with submassive pulmonary embolism (PE), who receive treatment using the Versus™ Catheter.
干预措施: Versus™ Endovascular Pulmonary Artery Drug Delivery Catheter (Device)
结局指标
主要结局
Blood Clot resolution
时间窗: Within one week of hospital admission
Number of patients achieving hemodynamic homeostasis as evidenced by pulmonary artery pressure indicating resolution of a pulmonary blood clot
Physician user experience
时间窗: Periprocedural
Number of physicians who rate use of the Versus Catheter as "Good \& Acceptable" or "Very good \& Acceptable" on a four-point scale
次要结局
未报告次要终点