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.
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;
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.
180
Cohort
Prospective
Percutaneous mechanical thrombectomy by ClotTriever System
Procedure/SurgeryThe procedure is performed via the ipsilateral popliteal vein access or the ipsilateral femoral vein access. After puncture under fluoroscopic or ultrasound guidance, a vascular sheath is inserted, systemic heparinization is administered, and a guidewire is advanced antegradely into the inferior vena cava with the assistance of a catheter to establish the access. Once the access is established, treatment is carried out using stent retriever devices. Available stent retriever devices include currently marketed options such as ClotTriever (INARI MEDICAL, USA). After thrombectomy, the thrombus removal efficacy is assessed by venography.
Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy
Procedure/SurgeryThe procedure is performed via the ipsilateral calf deep vein access, the ipsilateral popliteal vein access, or the ipsilateral femoral vein access. After puncture under fluoroscopic or ultrasound guidance, a vascular sheath is inserted, systemic heparinization is administered, and a guidewire is advanced antegradely into the inferior vena cava with the assistance of a catheter to establish the access. Once the access is established, treatment is carried out using mechanical aspiration thrombectomy devices. Available aspiration thrombectomy devices include currently marketed options such as the AngioJet thrombectomy catheter (Boston Scientific, USA) and the Acostream thrombectomy catheter (Acotec, China). After thrombectomy, the thrombus removal efficacy is assessed by venography.
Incidence of PTS
Assessed by the Villalta score
Incidence of moderate-to-severe PTS
Assessed by the Villalta score
Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
Based on clinical symptoms
Patency rate of the ipsilateral iliofemoral vein
Assessed by color Doppler ultrasound
Incidence of PTS
at 6 and 12 months
Incidence of major bleeding
Defined by International Society on Thrombosis and Haemostasis (ISTH) criteria
Incidence of symptomatic Pulmonary Embolism (PE)
Assessed by symptoms combined with contrast-enhanced computed tomography examination
Incidence of symptomatic Venous Thromboembolism (VTE)
Assessed by symptoms combined with ultrasound and contrast-enhanced computed tomography examination
All-cause mortality
All-cause death
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RenJi Hospital
Lead sponsor
Changhai Hospital
Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
Wenzhou Central Hospital
Collaborator
West China Hospital
Collaborator
Chengdu University of Traditional Chinese Medicine
Collaborator
First People's Hospital of Hangzhou
Collaborator
