Patients with iliofemoral vein thrombosis are prone to developing post-thrombotic syndrome (PTS). The profunda femoris vein (PFV) is an important inflow of the iliofemoral vein. Profunda femoris vein thrombosis clearance (PFV-TC) may improve the patency of iliofemoral vein and reduce the occurrence of PTS.
Age ≥ 18 years and ≤ 85 years;
Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and PFV (confirmed by preoperative ultrasound, CT venography, or intraoperative venography);
Time from symptom onset to endovascular treatment ≤ 14 days;
Patient receives endovascular treatment with PMT;
Presence of pre-existing PTS in the limb scheduled for treatment, 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 media, or other relevant agents;
Concomitant severe pulmonary embolism with hemodynamic compromise, such as hypoxia or hypotension;
Parallel
Percutaneous mechanical thrombectomy with profunda femoris vein thrombosis clearance (PMT with PFV-TC)
Procedure/SurgeryPMT with PFV-TC group (experimental group): Based on the control group, access is obtained via the contralateral common femoral vein using a crossover technique, or via a branch of the ipsilateral femoral vein to PFV. The thrombus status of the PFV is assessed, and PMT is performed on the PFV thrombosis. After thrombectomy, venography is performed to evaluate the patency of the PFV, and the thrombus removal grade before and after the procedure is assessed using the following scoring system: 0 points: no thrombus, patent lumen; 1 point: segmental thrombus, partially patent lumen; 2 points: segmental thrombus, occluded lumen; 3 points: fully filled with thrombus, completely occluded lumen.
Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)
Procedure/SurgeryAn appropriate puncture approach is selected, including the ipsilateral calf vein, ipsilateral popliteal vein, or ipsilateral femoral vein. Under ultrasound guidance, a vascular sheath is inserted after puncture, and systemic heparinization is performed. Using a guidewire and catheter, the guidewire is advanced antegradely into the inferior vena cava to establish a pathway. After the pathway is established, PMT is performed using a mechanical thrombectomy device. Acceptable thrombectomy devices include commercially available mechanical aspiration thrombectomy devices such as the AngioJet catheter (Boston Scientific, USA) and the Acostream catheter (Acotec, China). After thrombectomy, the outcome is evaluated by venography. If iliac vein stenosis greater than 50% is detected, balloon dilation is performed using a balloon matched to the normal vessel diameter. If residual stenosis remains greater than 50% after balloon dilation, the operator decides whether to place a stent. In cases wh
Incidence of Post-Thrombotic Syndrome (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
Assessed by the Villalta score
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
Wenzhou Central Hospital
Collaborator
West China Hospital
Collaborator
Chengdu University of Traditional Chinese Medicine
Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
Changhai Hospital
Collaborator
First People's Hospital of Hangzhou
Collaborator
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