Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 6
- 主要终点
- The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication
研究概览
简要总结
To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.
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 requires closure of femoral artery puncture resulting from arterial access procedure.
- •Patient is ≥18 years of age.
- •Patient is willing to provide written informed consent prior to study device use.
- •Patient is willing and able to adhere to data collection and follow-up requirements.
排除标准
- •Patient is participating in another clinical trial which has the potential to impact hemostasis.
- •Patient has an active groin infection or systemic infection.
- •Patient has undergone a vascular access procedure within the past 90 days.
- •Patient has been previously enrolled in the study. (For patients undergoing multiple interventions within a timeframe of 90 days, only the initial procedure may constitute a study enrollment.)
结局指标
主要结局
The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication
时间窗: 30 days post procedure
Major vascular complications include: Access Site Complications: * Hematoma \>10 cm in size requiring surgical or percutaneous intervention * Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention * Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention * Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics * A/V Fistula requiring medical intervention (percutaneous or surgical) * Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical)
The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.
时间窗: within 5 minutes of device deployment
次要结局
未报告次要终点