Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: modified access group modified access: PMT was performed via distal calf venous access or contralateral femoral 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.
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| Active Comparator: traditional access group 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.
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Outcome Measures
Primary Outcome Measures
- Incidence of post-thrombotic syndrome (PTS) [24 months]
Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months
Secondary Outcome Measures
- Immediate patency rate [immediately after lonely mechanical thrombectomy]
Percentage of patency rate immediately after lonely mechanical thrombectomy
- Total time of interventional surgery [immediately after interventional surgery]
Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)
- Total dosage of urokinase [immediately after interventional surgery]
Total dosage measured by units of urokinase used for procedure
- Patency rate of lower limb vein [post-interventional 24 months]
Percentage of patency rate of lower limb vein at post-interventional 24 months
- Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score [post-interventional 24 months]
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.
- Re-intervention rate [within 24 months after operation]
Percentage of re-intervention rate within 24 months after operation
- Rate of catheter-directed thrombolysis [immediately after interventional surgery]
Percentage of catheter-directed thrombolysis after mechanical thrombectomy
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 18-80 years old;
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Acute DVT with clinical symptoms occurred less than 14 days since the onset of disease;
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DVT with thrombosis involving iliac vein, femoral vein popliteal vein and calf vein;
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Informed consent signed by patients.
Exclusion Criteria:
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Patients with the previous history of the same side of lower-limb DVT;
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Patients with plasma Creatinine level greater than 180umol/L;
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Patients who are contraindicated to thrombolysis;
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Patients with inferior vena cava thrombosis;
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Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
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Patients who have participated in a clinical trial in the past three months;
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Women during pregnancy and lactation
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Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<2 years);
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Patients with autoimmune thrombopathy
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Patients who are unable or unwilling to participate in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Renji Hospital | Shanghai | Shanghai | China | 200127 |
Sponsors and Collaborators
- RenJi Hospital
- First People's Hospital of Hangzhou
- The First Affiliated Hospital with Nanjing Medical University
- Affiliated Hospital of Nantong University
- Chengdu University of Traditional Chinese Medicine
- Second Affiliated Hospital of Suzhou University
Investigators
- Study Director: Meng Ye, M.D., Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- The Reformation Study