Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis (The COMET Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- RenJi Hospital
- Enrollment
- 180
- Locations
- 1
Study Overview
Brief 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.
Detailed Description
Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. There is currently a lack of research on which device is optimal for thrombus removal. The aim of this study is to conduct a multicenter, observational, prospective cohort study in patients with acute iliofemoral deep vein thrombosis (DVT), performing a head-to-head comparison of two different types of mechanical thrombectomy devices - ClotTriever System versus aspiration thrombectomy (including rheolytic thrombectomy) - 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged between 18 and 85 years;
- •Diagnosed with acute iliofemoral venous thrombosis, with thrombosis involving at least the iliac vein and common femoral vein;
- •Time from symptom onset to endovascular treatment ≤ 14 days;
- •Patients undergo endovascular treatment with percutaneous mechanical thrombectomy;
- •Patients sign the informed consent form.
Exclusion Criteria
- •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;
- •Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;
- •Known allergy to heparin, low molecular weight heparin, contrast agents, etc.
- •Concomitant severe pulmonary embolism with hemodynamic changes, such as hypoxia, hypotension, etc.
- •Inability to tolerate endovascular treatment due to conditions such as acute systemic illness, severe dyspnea, etc.
- •Concomitant severe renal insufficiency with creatinine clearance < 30 ml/min;
- •Concomitant active bleeding, severe hepatic insufficiency, bleeding tendency, etc.
- •Concomitant severe anemia (hemoglobin < 8.0 mg/dL) or platelet count < 80,000/mL;
- •History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm;
- •Pregnant women;
- •Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency, etc.) with an expected life expectancy < 24 months
- •Participation in any drug or medical device clinical trial that may interfere with this study within the past 1 month;
- •Patients unwilling to participate in this trial.