SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism (NCT04948502) | Clinical Trial Compass
CompletedNot Applicable
SaExten Vena Cava Filter System in Prevention of Pulmonary Embolism
China192 participantsStarted 2020-08-13
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years old and life expectancy ≥ 12 months;
✓. The diameter of inferior vena cava is between 18.0mm and 26.0mm;
✓. Patients with acute (≤14 days of onset) proximal (inferior lumen, iliac, femoral, popliteal vein) deep vein thrombosis (DVT), or at risk of pulmonary embolism (PE) caused by thrombus detoxification, with or without symptoms of pulmonary embolism;
✓. People at risk of pulmonary embolism (PE) meet at least one of the following conditions:
✓. Those who can understand the purpose of the trial, cooperate with the follow-up, and sign the informed consent voluntarily.
Exclusion criteria
✕. Patients with severe stenosis or deformity of the inferior vena cava or severe spinal deformity;
✕. Patients with uncontrolled infectious diseases, purulent embolism or fat embolism;
✕. With disease causing difficulties in treatment and evaluation (such as septicemia, bacteremia, toxemia, severe metabolic disease, cancer metastasis, mental illness, etc.);