Acute iliofemoral deep vein thrombosis
Conditions
Interventions
Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance:Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance
Percutaneous mechanical thrombectomy with profunda femoris vein thrombosis clearance:Percutaneous mechanical thrombectomy with profunda femoris vein thrombosis clearance
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 85 years; 2.Diagnosed with acute iliofemoral venous thrombosis, with thrombosis involving the iliac vein and common femoral vein, and presence of thrombus in the profunda femoris vein (confirmed by preoperative ultrasound, contrast CT, or venography); 3.Time from symptom onset to endovascular treatment <=14 days; 4.Patients undergo endovascular treatment with percutaneous mechanical thrombectomy; 5.Patients sign the informed consent form
Exclusion criteria
Exclusion criteria: 1.Presence of PTS in the limb to be treated in this procedure, or a history of symptomatic DVT in the same limb within the past 2 years; 2.Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb; 3.Known allergy to heparin, low molecular weight heparin, contrast agents, etc. 4.Concomitant severe pulmonary embolism with hemodynamic changes, such as hypoxia, hypotension, etc. 5.Inability to tolerate endovascular treatment due to conditions such as acute systemic illness, severe dyspnea, etc. 6.Concomitant severe renal insufficiency with a creatinine clearance < 30 mL/min; 7.Presence of active bleeding, severe hepatic insufficiency, bleeding tendency, etc. 8.Concomitant severe anemia (hemoglobin < 8.0 mg/dL) or platelet count < 80,000/mL; 9.History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm; 10.Pregnant women; 11.Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency, etc.) with an expected life expectancy < 24 months; 12.Participation in any drug or medical device clinical trial that may interfere with this study within the past 1 month; 13.Patients unwilling to participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Post-Thrombotic Syndrome (PTS) at 24 months post-procedure (assessed by the Villalta score); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic venous thromboembolism (VTE) within 24 months;Incidence of major bleeding within 24 months;The clinical classification of the CEAP classification at 6 months, 12 months, and 24 months postoperatively;Mortality rate within 24 months;Reintervention rate within 24 months;The patency rate of the ipsilateral iliofemoral vein at 12 months and 24 months postoperatively;Incidence of Post-Thrombotic Syndrome (PTS) at 6 months and 12 months post-procedure;The incidence of moderate-to-severe post-thrombotic syndrome (PTS) at 6 months, 12 months, and 24 months postoperatively;Quality of life scores at 6, 12, and 24 months postoperatively;Recurrence rate of symptomatic DVT in the affected limb within 24 months;Incidence of symptomatic pulmonary embolism within 24 months; | — |
Countries
China
Contacts
Public ContactQihong Ni
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed