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.
Acute lower extremity deep vein thrombosis (DVT) can lead to obstruction of veins, causing sudden lower limb swelling. Patients may also develop post-thrombotic syndrome (PTS) manifesting as recurrent lower limb swelling, skin disorders, and even non-healing ulcers, which severely affects the patient's quality of life. Among lower extremity DVT, thrombosis involving the iliofemoral veins is the most severe, with an incidence of PTS as high as 20%-50%.1 Percutaneous mechanical thrombectomy (PMT) utilizes mechanical aspiration to rapidly remove thrombus, relieve venous obstruction, and restore luminal patency. According to the results of a prospective clinical study, PMT can effectively improve the primary thrombus clearance rate and shorten hospital stay in patients with DVT. Among 329 patients, 192 (58.5%) achieved complete thrombus removal using the AngioJet catheter.2 PMT was once considered to be the first-line treatment option for DVT. However, the results of the ATTRACT study, published in 2017 in New England Journal of Medicine, sparked considerable controversy regarding the use of PMT for DVT. The ATTRACT study found that there was no significant difference in the incidence of PTS at two years after PMT compared with anticoagulation alone.3 Although PMT can rapidly remove thrombus, is it unable to improve the long-term outcomes for patients with DVT? According to previous studies, the primary patency rate at 12 months after PMT for acute iliofemoral venous thrombosis ranges from 77% to 85%,4,5 while the incidence of PTS at 24 months postoperatively is as high as 40%.3 Residual thrombus is an important cause of thrombus recurrence, re-occlusion of the vein, and poor clinical outcomes.5 Previous studies have primarily focused on thrombus clearance in the popliteal vein, superficial femoral vein, common femoral vein, and iliac vein,6 while neglecting the assessment and clearance of profunda femoris vein (PFV) thrombosis. As the PFV is an important inflow of the iliofemoral vein, whether PFV-TC can improve the patency rate and clinical outcomes of endovascular treatment for acute iliofemoral DVT remains unclear. In our preliminary study, we analyzed and compared two cohorts: one receiving conventional endovascular treatment for acute iliofemoral venous thrombosis, and the other receiving conventional treatment combined with Profunda femoris vein thrombosis clearance (PFV-TC). The results showed that the 24-month patency rate of the iliofemoral vein was 90% vs. 72%, and the incidence of PTS was 11% vs. 32% (P\<0.05).7 These findings were published in November 2025 in European Journal of Vascular and Endovascular Surgery. This study has garnered widespread attention, and de Wolf MAF published an editorial commentary on this study,8 acknowledging the value of this approach in the endovascular treatment of acute iliofemoral DVT. Therefore, we hypothesize that PFV-TC can improve inflow and reduce the incidence of PTS for iliofemoral DVT. However, high-level evidence is still lacking. The present study is a prospective, multicenter, randomized, open-label, evaluator-blinded, 1:1 parallel-controlled clinical trial investigating PFV-TC, aiming to obtain higher-level evidence to guide endovascular treatment of acute iliofemoral DVT. References: 1. Di Nisio M, van Es N, Buller HR. Deep Vein Thrombosis and Pulmonary Embolism. Lancet. 2016,388:3060-3073. 2. Garcia M J, Lookstein R, Malhotra R, et al. Endovascular Management of Deep Vein Thrombosis with RheolyticThrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJetRheolyticThrombectomy with a Variety of Catheter Lengths) Registry. J Vasc Interv Radiol. 2015,26(6):777-785. 3. Vedantham S, Goldhaber SZ, Julian JA, et al. Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis. N Engl Med. 2017,377(23):2240-2252. 4. Attaran R R, Ozdemir D, Lin I H, et al. Evaluation of anticoagulant and antiplatelet therapy after iliocaval stenting: Factors associated with stent occlusion. J Vasc Surg Venous Lymphat Disord,2019,7(4):527-534. 5. Ni Q, Zhao Y, Xue G, et al. Directional femoral ultrasound-guided compression technique using in percutaneous mechanical thrombectomy for acute deep vein thrombosis: a retrospective cohort study. J Endovasc Ther, 2026;33(1):473-481. 6. Ni Q, Long J, Guo X, et al. Clinical efficacy of one-stage thrombus removal via contralateral femoral and ipsilateral tibial venous access for pharmacomechanical thrombectomy in entire-limb acute deep vein thrombosis\[J\]. J Vasc Surg Venous Lymphat Disord, 2021, 9(5): 1128-1135. 7. Ni Q, Liu Y, Chen J, Guo X, Wang W, Ye M, Wang Q, Zhang L. Outcomes of Profunda Femoris Vein Thrombosis Evaluation and Clearance by Percutaneous Mechanical Thrombectomy for Acute Iliofemoral Deep Vein Thrombosis. Eur J Vasc Endovasc Surg. 2025 Nov 3: S1078-5884(25)01002-0. 8. de Wolf MAF, Bijdevaate DC. Leave No Vein Behind. Eur J Vasc Endovasc Surg. 2025 Nov 13:S1078-5884(25)01129-3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
PMT 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.
An 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
Renji hospital
Shanghai, China
Incidence of Post-Thrombotic Syndrome (PTS)
Assessed by the Villalta score
Time frame: at 24 months
Incidence of moderate-to-severe PTS
Assessed by the Villalta score
Time frame: at 6, 12, and 24 months
Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
Based on clinical symptoms
Time frame: at 6, 12, and 24 months
Patency rate of the ipsilateral iliofemoral vein
Assessed by color Doppler ultrasound
Time frame: at 12 months and 24 months
Incidence of PTS
Assessed by the Villalta score
Time frame: at 6 and 12 months
Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)
Assessed by symptoms combined with ultrasound examination in the ipsilateral limb
Time frame: at 24 months
Rate of re-intervention
Assessed by documentation of clinical reintervention
Time frame: at 24 months
Quality of life score
Assessed by Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire (VEINES-QOL)
Time frame: at 6, 12, and 24 months
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