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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
After the implantation of Fitaya Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
After the implantation of Aegisy Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
The clinical success rate of the filter 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.
Time frame: 6 months after implantation
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Liuzhou Worker's Hospital
Liuchow, Guangxi, China
RECRUITINGAffiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, China
RECRUITINGUnion Hospital Tongji College Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGThe Affiliated Hospital of Shandong University of TCM
Jinan, Shandong, China
RECRUITINGShanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGSecond Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
RECRUITINGTianjin People's Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGTianjing Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITING...and 3 more locations