Safety and Efficacy Study of Fitaya Vena Cava Filter
赞助:
Lifetech Scientific (Shenzhen) Co., Ltd.
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | December 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
The clinical success rate of the filter implantation[ Time Frame: 6 months after implantation ] The clinically successful implantation of vena cava filter should meet the following three requirements simultaneously: 1. The filter was successfully implanted and the shape and positioning were satisfactory. 2. No symptomatic pulmonary embolism occurred in patients with permanent filter implantation within 6 months after implantation and was confirmed by Computed Tomography Pulmonary Angiography (CTPA). No symptomatic pulmonary embolism occurred in patients who had a removal of the filter during its indwelling and was confirmed by CTPA. 3. No rupture, no displacement, no venous penetration, no vena occlusion, no filter implantation or operation-related deaths occurred in the blood vessels. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Safety and Efficacy Study of Fitaya Vena Cava Filter | ||
| 正式标题 ICMJE | Safety and Efficacy Study of Fitaya Vena Cava Filter for Deep Vein Thrombosis: A Multi-center, Randomized Controlled Trial | ||
| 简要概况 | A Multi-center, Randomized Controlled Trial to evaluate the safety and efficacy of Fitaya Vena Cava Filter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for deep vein thrombosis. |
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| 详细说明 | The trial was mainly for patients with high-risk deep vein thrombosis, and all subjects who passed the screening and signed the informed consent will be enrolled and be randomly divided into the experimental group and the control group according to the proportion of 1:1. For patients who will be allocated to the experimental group will be implanted with Fitaya Vena Cava Filters System, and for patients who will be allocated to the control group will be implanted with Aegisy Vena Cava Filters. Between 0 and 60 days, after the filter was implanted, the investigator will decide whether to withdraw the vena cava filter based on the subject's condition. If successfully withdraw the vena cava filter, the subject will be followed up for 1 month, if the withdraw is unsuccessful, the subject will be followed up for 180 days. This clinical trial is conducted in qualified clinical trial institutions with a planned duration of 16-24 months. Upon completion of the clinical trial report, it will be submitted together with other materials for the application for listing registration in the China Food and Drug Administration (CFDA). | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
186 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2020 | ||
| 预计主要完成日期 | December 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Older or equal to 18 years of age, regardless of sex. 2. Patients are able to understand the purpose of the trial, voluntarily participated in and signed informed consent, and are willing to complete the follow-up as required by the program. 3. Patients diagnosed with inferior deep vein thrombosis (inferior vena cava, Iliac, femoral or popliteal DVT) or pulmonary embolism (PE), and concomitant with one or more of the following situation: 1. with the existence of contraindications for anticoagulation therapy. 2. complications such as bleeding occurred during anticoagulation therapy. 3. pulmonary embolism still recurred after adequate anticoagulation therapy. 4. All reasons cannot achieve sufficient anticoagulant. 5. PE coexist with inferior DVT. 6. Free thrombosis or large amounts of thrombosis are found in the iliac, femoral, popliteal or inferior vena cava. 7. Patients with acute risk factors of DVT and PE needed to undergo abdominal, pelvic or lower limb surgery simultaneously. 8. The patients had acute DVT, intend to do Catheter-Directed Thrombolysis (CDT, Percutaneous Mechanical Thrombectomy (PMT), or surgical thrombectomy. 4. The investigator determined that the patient had an appropriate femoral or jugular access for implantation of the filter. 5. The diameter of inferior vena cava intended to implant the filter is between 18mm and 29mm. Exclusion Criteria: 1. Had been implanted with an inferior vena cava filter previously. 2. There is thromboembolism in the jugular or femoral vein access of the filter implantation. 3. Intended to permanently implant the filter. 4. Severe spinal deformity may affect the implantation or removal of filters. 5. Renal vein thrombosis, or, inferior vena cava thrombosis spread to renal vein. 6. Congenital malformation of inferior vena cava. 7. Having an uncontrolled infectious disease, such as bacteremia or toxaemia. 8. Active malignant tumour and tumour metastasis. 9. Allergic to imaging agents, materials of filters and conveyor (including nickel and titanium, polyester, Polytetrafluoroethylene (PTFE), nylon polymer materials). 10. Patients with X-ray contraindication. 11. Liver dysfunction: Alanine transaminase (ALT) or Aspartate transaminase (AST) was 2.5 times higher than the normal upper limit, Serum creatinine (Cr) was two times higher than the normal upper limit. 12. Abnormal coagulation function in patients: activated part of thrombin time (APTT)10s more than the normal value. 13. Patients with a life expectancy less than 12 months. 14. Patients with severe heart and lung dysfunction. 15. Pregnant or lactating, or woman planned to be pregnant. 16. The patients participated in clinical trials of other drugs or medical devices and did not come out of the group or withdraw within the first 3 months of the screening period of this trial. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Lifetech Scientific (Shenzhen) Co., Ltd. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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