Pulmonary embolism
Conditions
Interventions
test group:The patients will be placed the Ballet vena cava filters of Weiqiang Medical Technology Co.,Ltd
control group:The patients will be placed the vena cava filters of Lifetech Medical Technology Co.,Ltd
Sponsors
Shanghai Sixth People's Hospita; Fudan University, Zhongshan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Subject aged = 18 years; 2 The subject himself signs or the legal representative signs the informed consent form; 3 The investigators confirm that patients with high-risk pulmonary embolism meet one of the following conditions; (1) Patients with pulmonary embolism or inferior or femoral condyle vein thrombosis meet one of the following conditions: There are contraindications for anticoagulant therapy; There are complications such as bleeding during anticoagulant therapy; Pulmonary embolism still recur after adequate anticoagulant therapy or adequate anticoagulation cannot be achieved for various reasons. (2) There are free thrombi or massive thrombi in the iliac crest, femoral vein or inferior vena cava. (3) Patients diagnosed with thrombophilia and recurrent pulmonary embolism. (4) Patients with acute deep venous thrombosis of the lower extremities and requiring catheter thrombolysis and thrombectomy.
Exclusion criteria
Exclusion criteria: 1 The subject is in pregnancy or lactation; 2 The subject is participating in other drug or medical device clinical trials and has not completed the study To study the end point; 3 Subject with chronic inferior vena cava thrombosis, or severe inferior vena cava stenosis; 4 The subject has a large area of pulmonary embolism, the condition is critical, and the person is near death; 5 Subjects are allergic to contrast agents and anesthetics; 6 Other situations in which the investigator determines that it is not appropriate for endovascular treatment, such as mental retardation, unable to match and so on.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of no pulmonary embolism from the time of implantation to removal of the vena cava filter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate of vena cava filter implantation;Immediate clinical success rate of vena cava filter implantation;Vascular venous filter removal technology success rate;Incidence of pulmonary embolism within 30 days of removal of vena cava filter;The incidence of adverse events;The incidence of no vena cava obstruction, filter breakage, discount, perforation, displacement (> 2cm), tilt (>15 degrees) from the time of implantation to removal of the vena cava filter; | — |
Countries
China
Contacts
Public ContactSun Yan
Outcome results
None listed