NCT03691753

Safety and Efficacy Study of Fitaya Vena Cava Filter

Safety and Efficacy Study of Fitaya Vena Cava Filter for Deep Vein Thrombosis: A Multi-center, Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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).

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DEVICE	Fitaya Vena Cava Filter System	After the implantation of Fitaya Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
DEVICE	Aegisy Vena Cava Filter	After the implantation of Aegisy Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.

Timeline

• Start date: 2018-09-29
• Primary completion: 2020-04-01
• Completion: 2020-12-01
• First posted: 2018-10-02
• Last updated: 2020-02-17

Locations

13 sites across 1 country: China