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.
Age between 18-85 years old;
Acute DVT occurred no more than 14 days since the onset of disease;
DVT treated by percutaneous mechanical thrombectomy
Informed consent signed by patients.
Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
Women during pregnancy and lactation;
Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<6 months);
Patients who are unable or unwilling to participate in the study.
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.
Cohort
Prospective
Percutaneous mechanical thrombectomy (PMT) by the modified approach
Procedure/SurgeryThe 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.
Percutaneous mechanical thrombectomy (PMT) by the traditional approach
Procedure/SurgeryThe 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.
Traditional approach
Procedure/SurgeryThe 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
Rate of catheter-directed thrombolysis
Percentage of catheter-directed thrombolysis after mechanical thrombectomy
Total time of interventional surgery
Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)
Total dosage of urokinase
Total dosage measured by units of urokinase used for procedure
Patency rate of lower limb vein
Percentage of patency rate of lower limb vein evaluated by ultrasound
Major bleeding rate
Major bleeding defined by International Society on Thrombosis and Haemostasis (ISTH)
Venous thromboembolism recurrence rate
Symptomatic venous thromboembolism recurrence including deep venous thrombosis and pulmonary embolism
All-cause death rate
All-cause death during the follow-up period
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RenJi Hospital
Lead sponsor
First People's Hospital of Hangzhou
Collaborator
Chengdu University of Traditional Chinese Medicine
Collaborator
