Acute iliofemoral deep venous thrombosis
Conditions
Interventions
Experimental group:Mechanical thrombectomy catheter
Sponsors
The First Hospital of Peking University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or non pregnant or lactating female subjects aged 18 to 80 years; 2. Subjects diagnosed with acute iliofemoral deep venous thrombosis; 3. Subjects who can understand the purpose of the test, voluntarily participate in and sign informed consent, and are willing to follow up.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with pulmonary embolism; 2. The affected limb has a history of DVT; 3. Severe liver and kidney diseases (creatinine > 200 umol/L, ALT/AST > 3 x ULN or TBIL > 2 x ULN); 4. Active bleeding (severe gastric and duodenal ulcer); 5. Subjects with bleeding prone constitution (platelet count < 50 x 10^9/L); 6. Hemorrhagic stroke; 7. Severe hypertension; 8. Thrombolytic therapy in recent 1 month; 9. Subjects allergic to contrast media; 10. The guide wire cannot pass through the target lesion; 11. Intraoperative contrast vein diameter < 3 mm; 12. Subjects whose life expectancy is less than 12 months (such as advanced malignant tumor).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thrombus clearance;Thrombus recurrence rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Venous patency rate at 1, 6 and 12 months after operation;Incidence of postoperative complications (DVT related death, severe bleeding, clinical symptoms, pulmonary embolism) ;Incidence of post thrombotic syndrome ;Incidence of serious adverse events at 1, 6 and 12 months after operation;Incidence of device related adverse events ; | — |
Countries
China
Contacts
Public ContactZou Yinghua
The First Hospital of Peking University
Outcome results
None listed