An interventional study of pharmacomechanical thrombectomy (PMT) in Deep Vein Thrombosis, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
Ipsilateral popliteal venous the most common access for pharmacomechanical thrombectomy (PMT) in the treatment of acute deep venous thrombosis (DVT), but the result was not satisfactory. The investigators adjust the access to improve the thrombus clearance rate and reduce the incidence of post-thrombotic syndrome (PTS).
Acute deep venous thrombosis (DVT) with whole lower limb involved is associated with significant post thrombotic morbidity. Both of deep venous occlusion and valvar reflux increase the risk for development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by pharmacomechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, ipsilateral popliteal venous the most common access for PMT. However, from this approach, it's hard to remove the thrombosis in the distal popliteal vein. So, the investigators hypothesize that the residual thrombus and slow blood-flow in the in-flow may weakened the efficacy of PMT, and by adjusting vein access approach could improve the thrombus clearance rate and reduce the incidence of PTS for whole leg DVT.
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Exclusion Criteria:
modified access: PMT was performed via distal calf venous access or contralateral femoral access
Device: pharmacomechanical thrombectomy (PMT)
traditional access: PMT was performed via ipsilateral popliteal venous access
Device: pharmacomechanical thrombectomy (PMT)
After randomization patients will be allocated to pharmacomechanical thrombectomy (PMT) via ipsilateral popliteal venous approach or to PMT via distal calf venous approach, bail-out contralateral femoral access can be used if puncture was failed in calf vein. After PMT treatment, residual thrombus was reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) was conducted if there was residual thrombus. Stenosis of iliac vein was assessed by multiangle venography and intravascular ultrasound (IVUS) was used if necessary. Percutaneous balloon angioplasty (PTA) was conducted if there was \>50% stenosis of the diameter of the iliac vein. A stent was placed if the residual stenosis was \>50% after PTA treatment.
Incidence of post-thrombotic syndrome (PTS)
Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months
Time frame: 24 months
Immediate patency rate
Percentage of patency rate immediately after lonely mechanical thrombectomy
Time frame: immediately after lonely mechanical thrombectomy
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 at post-interventional 12 and 24 months
Time frame: post-interventional 12 and 24 months
Deep venous valve function evaluation
Deep venous valve function evaluation by ultrasound at post-interventional 12 and 24 months
Time frame: post-interventional 12 and 24 months
Quality of life evaluated by 36-Item Short Form Health Survey (SF-36)
Quality of life evaluated by 36-Item Short Form Health Survey (SF-36). The change in SF-36 Physical and Mental Component Scales from baseline to 24 months will be compared between the two groups using a t-test. A difference of 5 points on each scale is considered to be clinically relevant. In addition, a linear mixed model analysis of the repeated assessments (3, 6, 12, and 24 months) with baseline scores as a covariate will be used to investigate the changes over time, and if they differ by treatment arm.
Time frame: post-interventional 3, 6, 12 and 24 months
Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score
Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score at post-interventional 24 months; The minimum value is 21, and the maximum value is 118. The higher scores mean a better outcome.
Time frame: post-interventional 3, 6, 12 and 24 months
European quality of life 5-dimension 5-level (EQ-5D-5L) score
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame: post-interventional 3, 6, 12 and 24 months
Re-intervention rate
Percentage of re-intervention rate within 24 months after operation
Time frame: within 24 months after operation
Rate of catheter-directed thrombolysis
Percentage of catheter-directed thrombolysis after mechanical thrombectomy
Time frame: immediately after interventional surgery
Safety outcomes - procedural complications
Procedural complications such as hematoma at the puncture site, hemoglobinuria or hemolytic jaundice
Time frame: Within 30 days after intervention
Safety outcomes - major bleeding events
Major bleeding events according to the International Society on Thrombosis and Haemostasis (ISTH)
Time frame: Within 24 months after intervention
all-cause death
All-cause death during the follow-up period
Time frame: Within 24 months after intervention
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