A Post Market Clinical Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on Patients Undergoing Surgical Treatment for the Removal of Arterial Emboli and/or Thrombi
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 3
- 主要终点
- Safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure
研究概览
简要总结
A post market clinical study to confirm the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on patients undergoing surgical treatment for the removal of arterial emboli and/or thrombi
详细描述
This prospective, single arm, post market clinical study was designed to proactively collect clinical data on the LeMaitre® TufTex Single Lumen Embolectomy Catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. This post market study is sponsored by LeMaitre® Vascular, Inc., the manufacturer of the device. Study will take place at 3 to 8 sites in Europe, the target sample size is 112 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Male and female subject, ≥ 18 years of age at time of enrollment.
- •Subject who is scheduled to undergo surgical treatment for the removal of arterial or venous emboli and/or thrombi, where one of the LeMaitre® Embolectomy Catheter will be used.
- •Subject signed an Informed Consent for participation.
- •Subject diagnosed with a embolus/thrombus.
- •Subjects for whom thrombolytic therapy had failed or was contraindicated.
排除标准
- •Co-morbidity that in the discretion of the investigator might confound the results.
- •Subjects who are unable to read or write.
- •Pregnant or lactating women at time of enrollment
- •Subjects who are immune comprised
结局指标
主要结局
Safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure
时间窗: During procedure and 1 month post index procedure
The primary safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure and 1 Month post index procedure.
Performance objective is the technical success as defined as <30% residual stenosis
时间窗: 1 month post index procedure
The primary performance objective is the technical success as defined as \<30% residual stenosis of the target vessel.
次要结局
- 2. Revision Rate(1 month post index procedure)
- 1. Clinical success(1 Month after the index procedure)
- 4. Secondary Patency(1 month post index procedure)
- 3. Primary Assisted Patency(1 month post index procedure)