A Post-market Clinical Study to Confirm the Performance and Safety of the LeMaitre TufTex Over-the-Wire (OTW) 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
- Performance objective is the technical success being <30% residual stenosis
研究概览
简要总结
A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
详细描述
This clinical investigation is a prospective, single-arm, multicenter, post-market study to proactively collect clinical data on the LeMaitre® TufTex Over-the-Wire (OTW) 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. The intended purpose of the device in this post market clinical study is identical to the indication of use of the device.
The TufTex OTW post-market study is initiated by the Sponsor and manufacturer of the device, LeMaitre Vascular, Inc.
The investigation will take place in 4 sites, most likely in 3 different countries. A total number of 112 subjects is anticipated to be enrolled, who are intended to undergo surgical treatment for the removal of a emboli and/or thrombi. The anticipated enrollment period is 48 months, and the participation per subject is 1 month. The total study duration is expected to be 56 months (4 months start-up, 48 months of recruitment, 1 month of follow-up, 3 months of closure.
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
- •Male and female subject, ≥ 18 years of age at time of enrollment.
- •Subject who is scheduled to undergo surgical treatment for the removal of an emboli or thrombi during an embolectomy and/or thrombectomy procedure, 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 compromised
结局指标
主要结局
Performance objective is the technical success being <30% residual stenosis
时间窗: 1 month post index procedure
The primary performance objective of the study is the technical success as defined as \<30% residual stenosis of the target vessel as evaluated on the completion digital subtraction angiography (DSA).
Safety objective is defined as acceptable safety outcomes during the procedure and at follow-up
时间窗: 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.
次要结局
- 1.Clinical success(1 month post index procedure)
- 3. Primary assisted patency(1 month post index procedure)
- 4. Secondary patency(1 month post index procedure)
- 2. Revision rate(1 month post index procedure)