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SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism

NCT04948502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2023-09-29

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • ShenZhen KYD Biomedical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Guangqi Chang, Dr. · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2022-01-20
Completion
2022-09-08

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04948502 on ClinicalTrials.gov