NCT04948502

SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism

A Multicenter, Randomized, Positive-controlled Clinical Trial to Verify the Efficacy and Safety of the SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: ShenZhen KYD Biomedical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of SaExten vena cava filter (VCF) system (ShenZhen KYD BioTech Co., Ltd., China) in prevention of pulmonary embolism (PE). This is a prospective, multicenter, randomized controlled, positive-controlled clinical trial, which will enroll 204 participants in total. Participants will undergo interventions with SaExten VCF System or Denali filter (C. R. BARD, Inc., USA).

Detailed description

The purpose of this study is to evaluate the efficacy and safety of SaExten vena cava filter (VCF) system in prevention of pulmonary embolism (PE). This is a prospective, multicenter, randomized controlled, positive-controlled clinical trial, which will enroll 204 participants in total, with 102 in each group. Participants will undergo interventions with SaExten VCF System or Denali filter, and be followed up to 12 months if the implantation is permanent, to evaluate the efficacy and safety of SaExten VCF System in prevention of PE.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	SaExten vena cava filter system	Subjects will undergo intervention, be implanted with a SaExten filter. The filter will be retrieved within 90 days or indwelled permanently, depending on the existence of thrombosis and the evaluation of the physician.
DEVICE	Denali inferior vena cava filter	Subjects will undergo intervention, be implanted with a Denali filter. The filter will be retrieved within 90 days or indwelled permanently, depending on the existence of thrombosis and the evaluation of the physician.

Timeline

• Start date: 2020-08-13
• Primary completion: 2022-01-20
• Completion: 2022-09-08
• First posted: 2021-07-02
• Last updated: 2023-09-29

Locations

16 sites across 1 country: China