Clinical Registry of St. Jude Medical Angio-Seal™ Vascular Closure Devices Following Interventional Radiology Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 634
- 试验地点
- 10
- 主要终点
- Rate of Major Vascular Complications
研究概览
简要总结
The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device.
- •Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.
排除标准
- •Patients who are unable to provide written informed consent.
结局指标
主要结局
Rate of Major Vascular Complications
时间窗: 30 days
Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure. The following are defined as a major vascular complication: 1. Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means; 2. Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention; 3. Access site related bleeding requiring transfusion; 4. New ipsilateral lower extremity ischemia requiring surgical intervention; 5. Retroperitoneal bleeding; 6. Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics; 7. Access related complication that results in extended hospital stay; 8. Death
次要结局
- Time to Hemostasis(Procedure)
- Rate of Minor Vascular Complications(30 days)
- Impact of Guided Access on Use of Closure Device.(30 days)
- Impact of Guided Access on Achieving Target Puncture Location.(30 days)
- Rate of Major Vascular Complications (MVCs) by Guided Access Mode.(30 days)
- Rate of Minor Vascular Complications by Guided Access Mode.(30 days)
- Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device(30 days)
- Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device(30 days)
- Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)(30 days)
- Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)(30 days)