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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;
. Previous vena cava filter implantation history;
. Thrombosis in the venous access required for the filter implantation;
. Patients with severe liver and renal dysfunction (ALT\>3 times the upper limit of normal; Creatinine\>225umol/L);
. Patients with known uncorrectable bleeding or severe coagulation disease;
. Patients who are allergic to contrast agents, nickel and have contraindication to X-ray;
. With disease causing difficulties in treatment and evaluation (such as septicemia, bacteremia, toxemia, severe metabolic disease, cancer metastasis, mental illness, etc.);