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 the proximal segment (orifice) of PFV (confirmed by preoperative ultrasound, CT venography, or pre-procedural 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;
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 popliteal-profunda communicating vessel approach 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. Successful PFV-TC is defined as the presence of continuous flow from the distal PFV to the CFV, including complete clearance (no residual thrombus) and partial clearance (continuous flow with residual thrombus). Conversely, the absence of continuous flow is defined as failed PFV-TC.
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 Indigo catheter (Penumbra Inc, USA). 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, stent implantation is performed.
Incidence of Post-Thrombotic Syndrome (PTS)
Assessed by the Villalta score. The Villalta scale is the recommended tool for diagnosing and grading the severity of PTS. It is a composite score based on 11 items (5 patient-reported symptoms and 6 clinician-assessed signs), each rated from 0 (absent) to 3 (severe), yielding a total score ranging from 0 to 33. A score of 0-4 indicates no PTS, whereas a score of ≥5 or venous ulcer confirms the diagnosis of PTS. Specifically, scores of 5-9 indicate mild PTS, 10-14 indicate moderate PTS, and a score of ≥15 or venous ulcer indicates severe PTS. Higher scores reflect greater disease severity.
Incidence of moderate-to-severe PTS
Assessed by the Villalta score
Patency rate of the ipsilateral iliofemoral vein
Assessed by color Doppler ultrasound
Incidence of PTS
Assessed by the Villalta score
Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)
Assessed by symptoms combined with ultrasound examination in the ipsilateral limb
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
