Safety and Efficacy Study of Fitaya Vena Cava Filter
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Venous Thromboembolism
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 all...
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).
Tracking Information
- NCT #
- NCT03691753
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Xiaoming Zhang, Professor Peking University People's Hospital