Perclose Multi-Access DUS Study: Assess the Safety and Performance of the Perclose ProGlide™ Suture-Mediated Closure (SMC) System and the Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System in Managing Multiple Venous Access Sites (Evaluation by DUS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge
研究概览
简要总结
The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years
- •Subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein
- •All the access sites are planned to be treated with Perclose SMC
- •Written informed consent is obtained prior to the procedure
排除标准
- •Visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure
- •Prior ipsilateral deep vein thrombosis within 6 months
- •International Normalization Ratio >3.5 for patients on warfarin
- •Subject who is not able to ambulate pre-procedure
- •Women who are pregnant (based on site standard pre-procedure pregnancy test)
- •Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months
结局指标
主要结局
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge
时间窗: Within 24 hours of procedure.
Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications.
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge
时间窗: Within 24 hours of procedure.
Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization.
次要结局
未报告次要终点