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NCT07622212
Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis
Conditions: Deep Vein Thrombosis
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Enrollment: 180
Sponsor: RenJi Hospital
Location: Renji hospital Shanghai
Summary
A head-to-head comparison of two different types of percutaneous mechanical thrombectomy (PMT) - ClotTriever System versus aspiration thrombectomy (including rheolytic thrombectomy) - in patients with acute iliofemoral deep vein thrombosis (DVT) was conducted to determine whether ClotTriever System can improve thrombus clearance rate, reduce the incidence of post-thrombotic syndrome (PTS), and enhance the long-term efficacy of endovascular treatment for acute iliofemoral DVT.
Eligibility Criteria
Inclusion Criteria:
1. Aged between 18 and 85 years;
2. Diagnosed with acute iliofemoral venous thrombosis, with thrombosis involving at least the iliac vein and common femoral vein;
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:
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 creatinine clearance \< 30 ml/min;
7. Concomitant 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.
Source: ClinicalTrials.gov (NCT07622212). StuddyBuddy aggregates publicly available trial information.
