An observational study in Deep Vein Thrombosis, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by RenJi Hospital · Observational
The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for iliofemoral deep venous thrombosis (DVT) with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis.
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. In general, PMT is performed through ipsilateral popliteal venous access as a traditional approach. However, the thrombosis in distal popliteal vein cannot be removed. Previous study demonstrated that the residual thrombus may decrease the efficacy of PMT. The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach for iliofemoral DVT with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.
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Patients with acute lower limb deep venous thrombosis (DVT) treated by percutaneous mechanical thrombectomy (PMT). The symptoms of DVT should no more than 14 days.
Exclusion Criteria:
Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral distal calf venous access or contralateral femoral access.
Procedure: Percutaneous mechanical thrombectomy (PMT) by the modified approach
Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral popliteal venous access.
Procedure: Percutaneous mechanical thrombectomy (PMT) by the traditional approach
Anterograde venography shows patients with iliofemoral DVT without distal popliteal vein thrombosis. PMT is performed via any access, such as ipsilateral femoral venous access or ipsilateral popliteal venous access.
Procedure: Traditional approach
The modified approach includes the ipsilateral calf venous access and the contralateral femoral venous access. Through contralateral femoral venous access, a hydrophilic guide wire and a catheter will be crossover through the thrombus side to the distal calf vein. The ipsilateral calf venous access will be punctured under the guidance of ascending venography. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \>50% stenosis of the diameter of the iliac vein.
The traditional approach will be punctured from the ipsilateral popliteal vein under ultrasound guidance. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \>50% stenosis of the diameter of the iliac vein.
The approach will be punctured from either the ipsilateral femoral vein or popliteal vein. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \>50% stenosis of the diameter of the iliac vein.
Incidence of post-thrombotic syndrome
Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score
Time frame: 24-month
Rate of catheter-directed thrombolysis
Percentage of catheter-directed thrombolysis after mechanical thrombectomy
Time frame: Immediately after interventional surgery
Total time of interventional surgery
Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)
Time frame: Immediately after interventional surgery
Total dosage of urokinase
Total dosage measured by units of urokinase used for procedure
Time frame: Immediately after interventional surgery
Patency rate of lower limb vein
Percentage of patency rate of lower limb vein evaluated by ultrasound
Time frame: 24-month
Incidence of post-thrombotic syndrome
Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score
Time frame: 12-month
Re-intervention rate
Percentage of re-intervention rate for the same limb
Time frame: 24-month
Major bleeding rate
Major bleeding defined by International Society on Thrombosis and Haemostasis (ISTH)
Time frame: 24 months
Venous thromboembolism recurrence rate
Symptomatic venous thromboembolism recurrence including deep venous thrombosis and pulmonary embolism
Time frame: 24 months
All-cause death rate
All-cause death during the follow-up period
Time frame: 24 months
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