Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System (ENTRUST)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 主要终点
- Major Adverse Events
研究概览
简要总结
The ENTRUST registry's objective is to collect real-world data (RWD) and health economic data on the ENROUTE™ Transcarotid Neuroprotection System (ENROUTE™ Transcarotid NPS), including populations in which outcomes of TCAR in patients with extracranial carotid artery disease are inadequately reported.
详细描述
A global prospective, single-arm, non-randomized, open-label, observational/non-interventional, multi-center registry to collect Real-World Data for TCAR procedure, including health economic data.
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
- •Patient is ≥ 18 years of age*
- •Written informed consent (patient data-release form)
- •Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease and specified in the Registry Enrollment Guide(s).
- •Refer to the Registry Enrollment Guide for details on enrollment restrictions based on patient age
排除标准
- •Life expectancy of < 1 year or patient is unlikely to derive net clinical benefit from carotid revascularization.
- •Patient has primary, recurrent or metastatic malignancy and does not have independent assessment of life expectancy of ≥5 years performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
研究组 & 干预措施
Extended Clinical Cohort
Patients who elect to be followed through 36 months are included in the Extended Clinical Cohort. Patients will complete assessments per standard of care through 36-months in North America.
干预措施: Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease (Device)
Clinical Cohort
All enrolled patients are included in the Clinical Cohort. Patients will complete assessments per standard of care through 12-months in North America.
干预措施: Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease (Device)
结局指标
主要结局
Major Adverse Events
时间窗: within 30 days (death, stroke, or MI); within 31-365 days (ipsilateral stroke)
Major Adverse Events (MAEs) defined as a composite outcome including any death, stroke, or myocardial infarction (MI) within 30 days of the index procedure and ipsilateral stroke within 31 days to 365 days of the index procedure. No pre-specified endpoints or formal tests of hypotheses are proposed. Analyses will be performed for exploratory purposes.
次要结局
未报告次要终点