Post Market Clinical Follow-up Study of the Precise Pro Rx Nitinol Stent System in the Treatment of Carotid Artery Disease (REAL-PRECISE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 4
- 主要终点
- Safety Endpoint - Myocardial Infarction
研究概览
简要总结
The purpose of this study is to evaluate long-term clinical safety and performance of the PRECISE PRO RX Nitinol Stent System to treat stenotic lesions of the carotid arteries.
详细描述
The REAL-PRECISE study is a multi-center, non-randomized, observational analysis of retrospective data collected on subjects treated with PRECISE PRO Rx Nitinol Stent System. The purpose of this study is to evaluate the long-term (5-year) safety and performance of PRECISE PRO Rx Nitinol Stent System in subjects with stenotic lesions of the carotid arteries. The study is conducted in up to 15 European study sites in approximately 3 countries with high volume use of PRECISE PRO Rx. The enrollment and data collection takes approximately 4-6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •NOTE: This is a RETROSPECTIVE study designed to collect outcomes on subjects who were already treated with the study device.
- •Inclusion Criteria:
- •Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis
- •If an EC-approved informed consent waiver is not obtained, then documented informed consent from the subject or legal representative granting permission to share the subject's clinical data
排除标准
- •Women who were pregnant or lactating at the time of the procedure
- •Pediatric subjects (<18 years of age) at the time of the procedure
研究组 & 干预措施
Subjects treated with the PRECISE PRO Rx Nitinol Stent System
Subjects treated with the PRECISE PRO Rx Nitinol Stent System according to the Instructions for Use for treatment of carotid artery stenosis
干预措施: PRECISE PRO Rx Nitinol Stent System (Device)
结局指标
主要结局
Safety Endpoint - Myocardial Infarction
时间窗: Through 5 years.
All site-reported events of myocardial infarction
Performance Endpoint - Technical Success
时间窗: At the conclusion of the index procedure
Achievement of a final residual stenosis of \<30% at the target lesion using any percutaneous method at the conclusion of the index procedure
Performance Endpoint - Target Lesion Revascularization (TLR) at 12 months
时间窗: At 12 months
A repeat revascularization procedure performed at the original treatment site due to restenosis of ≥50% at the target lesion (as confirmed by quantitative angiography) in the presence of symptoms or ≥80% in the absence of symptoms
Safety Endpoint - All-Cause Mortality
时间窗: Through 5 years
All site-reported events of all-cause mortality
Safety Endpoint - Major Stroke
时间窗: Through 5 years
A major stroke is defined as a cerebrovascular accident
Safety Endpoint - Minor Stroke
时间窗: Through 5 years
A minor stroke is defined as a transient ischemic attack
Safety Endpoint - Thrombosis
时间窗: Through 5 years
All site-reported events of thrombosis
次要结局
未报告次要终点