Deep venous thrombosis in the lower limbs
Conditions
Interventions
test group:Deep vein thrombosis clearance system for the treatment of deep vein thrombosis
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old, 85 years old, no gender limit; 2. Patients with imaging confirmed deep vein thrombosis of the lower limbs (within 30 days of onset); 3. The target lesion involves the iliac and / or femoral veins, and the minimum vessel diameter of the target lesion is 6mm; 4. Agree to participate in this study, and voluntarily sign the informed consent form, willing to accept and cooperate with the postoperative follow-up in the completion protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with a loss of local hemostasis at the puncture site; 2. Unable to establish access or guide wire through the lesion is difficult; 3. Patients with pulmonary embolism with circulatory instability; 4. Patients with recurrent deep vein thrombosis in the ipsilateral target limb; 5. Patients whose target lesion is implanted with venous stent, or inferior vena cava filter affecting device release; 6. Patients who need thrombus removal in the deep veins of both lower limbs in this operation; 7. Active bleeding within 30 days, including severe intracranial, gastrointestinal, urinary tract bleeding, etc. 8. A history of hemorrhagic or ischemic stroke within 30 days; 9. Patients with known coagulopathy or bleeding tendency (platelet count 2.5 mg/dl or 221 u mol/L, 3 times the upper limit of ALT or AST); 11. Patients known to have allergies to, or contraindication to, iodine-containing contrast agents, thrombolytic agents, anticoagulants, antiplatelet drugs and salicylate drugs; 12. Patients with a clear diagnosis of thromboembolism or rheumatic immune diseases caused by deep vein thrombosis; 13. Patients with diseases that may cause difficulties in treatment and evaluation (e. g., terminal malignancy, acute infectious disease, sepsis, systemic conditions that cannot tolerate surgery, etc.); 14. Women who are pregnant or breastfeeding, or those who are planning to become pregnant during the trial; 15. Are participating in the clinical trials of any other drug or medical device; 16. Other circumstances that the investigator judged not appropriate to participate in this clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Development of major adverse events (MAEs) at 1 month after surgery;Incident occurrence of serious adverse events related to the test device during the study;Incident occurrence of adverse events related to the test device during the study;Total serious adverse events occurred during the study period;Incidence of post-thrombotic syndrome (PTS) at 6 months after surgery;Venous patency rate at ONE month after surgery;Change from baseline in venous clinical severity score (VCSS) at 6 months after surgery;Incidence of post-thrombotic syndrome (PTS) at 1 months after surgery;Venous patency rate at SIX months after surgery;Total adverse events occurred during the study period;Change from baseline in venous clinical severity score (VCSS) at 1 month after surgery; | — |
Countries
China
Contacts
Public ContactLu Qingsheng
Shanghai Changhai Hospital
Outcome results
None listed