Prevention of pulmonary artery embolism
Conditions
Interventions
Experimental group:Vena cava filter developed by Shanghai Blue Vein Medical Technology Co., LTD
Control group:Denali Vena cava filter
Sponsors
Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Patients with the following conditions (any of the following) : (1) Patients with symptomatic PE or acute thrombosis of inferior vena cava and iliac, femoral and popliteal veins have one of the following conditions: 1) Patients with contraindications of anticoagulant therapy; 2) Bleeding and other complications occurred during anticoagulant therapy; 3) Recurrence of PE after adequate anticoagulant therapy and failure to achieve adequate anticoagulant for various reasons; (2) Patients with symptomatic PE and acute lower limb DVT; (3) Free floating thrombus or a large number of acute thrombus in iliac and femoral veins or inferior vena cava; (4) Patients diagnosed with thromboembolism and repeated occurrence of PE; (5) Patients with acute lower limb DVT who want to undergo transcatheter contact thrombolysis (CDT) or percutaneous mechanical thrombolysis (PMT); 3. The patients can understand the purpose of the experiment, voluntarily participate and sign the informed consent, and are willing to complete the follow-up as required by the project; 4. The investigator determined that there was a suitable transcervical or transfemoral approach; 5. The diameter of inferior vena cava is between 16-28mm.
Exclusion criteria
Exclusion criteria: 1. Patients who are preparing for pregnancy, pregnant or lactating; 2. Chronic inferior vena cava thrombosis with severe stenosis of the inferior vena cava; 3. History of previous vena cava filter surgery; 4. Renal vein thrombosis, or inferior vena cava thrombosis extending into the renal vein; 5. Patients with massive pulmonary artery embolism, in critical condition, who are already in a life-threatening condition; 6. The patient is allergic to contrast media, filter components, and anesthetics; 7. Planned implantation of permanent filters; 8. Severe abnormal liver or kidney function (alanine aminotransferase or aspartate aminotransferase 2.5 times above the upper limit of normal, serum creatinine 2 times above the upper limit of normal); 9. Severe coagulation dysfunction; 10. Uncontrollable infections, such as bacteraemia or toxaemia; 11. Patients with malignant neoplasm and a life expectancy of less than 12 months; 12. Patients who are participating in another drug or medical device clinical trial and have not completed the primary study endpoint of the study; 13. Other circumstances that are judged by the investigator to be inappropriate for endoluminal therapy, such as no suitable vascular access, inability to cooperate, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate of filter implantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate of filter implantation;Incidence of symptomatic pulmonary embolism during filter retention;Success rate of filter retrieval technique;Clinical success rate of filter retrieval;Duration of filter retention in the body;Incidence of inferior vena cava thrombosis;Incidence of filter dislocation;Incidence of filter fracture;Incidence of filter tilt;Incidence of filter penetration; | — |
Countries
China
Contacts
Public ContactLiu Jianlong
Outcome results
None listed