Prevention of pulmonary embolism
Conditions
Interventions
Experimental group:Thromboprotective device
Control group:Aegisy vena cava filter
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 years old; 2. Patients with any of the following conditions (one of the following is sufficient) (1) Percutaneous mechanical thrombus removal (PMT) or thrombectomy is required for acute DVT (2) Other intravenously operated procedures identified by the researchers as having a high risk of PE: for example, when the filter was recovered, it was found that the filter blocked a large number of thrombus, or deep vein thrombosis combined with iliac vein stenosis/occlusion required intravenously treated with balloon dilation and stent implantation 3. The subjects can understand the purpose of the experiment, voluntarily participate in and sign the informed consent, and are willing to complete the follow-up according to the requirements of the project; 4. The investigators determined that there was a suitable vascular approach; 5. Diameter of inferior vena cava =28mm.
Exclusion criteria
Exclusion criteria: 1. Pregnant women; 2. Symptomatic PE patients; 3. Anticoagulation contraindication; 4. The subject is allergic to any component of the test instrument; 5. Coagulation dysfunction, not suitable for endovascular surgery; 6. Uncontrollable infections, such as bacteremia or toxemia; 7. The subject is participating in another drug or medical device clinical trial and has not completed the primary study endpoint of the study yet; 8. Other conditions determined by the investigator to be inappropriate for endovascular therapy, such as lack of suitable vascular approach and inability to cooperate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate (before discharge or 3 days after surgery); | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Incidence of symptomatic PE;Thrombus interception rate;Incidence of device-related thrombosis;Incidence of device-related major bleeding;Incidence of inferior vena cava thrombosis; | — |
Countries
China
Contacts
Public ContactLu Qingsheng
Shanghai Changhai Hospital
Outcome results
None listed