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| Name | Class |
|---|---|
| First People's Hospital of Hangzhou | OTHER |
| Chengdu University of Traditional Chinese Medicine | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the modified access | 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. |
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| Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the traditional access | Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral popliteal venous access. |
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| Iliofemoral DVT without distal popliteal vein thrombosis treated by PMT | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous mechanical thrombectomy (PMT) by the modified approach | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-thrombotic syndrome | Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score | 24-month |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of catheter-directed thrombolysis | Percentage of catheter-directed thrombolysis after mechanical thrombectomy | Immediately after interventional surgery |
| Total time of interventional surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding rate | Major bleeding defined by International Society on Thrombosis and Haemostasis (ISTH) | 24 months |
| Venous thromboembolism recurrence rate | Symptomatic venous thromboembolism recurrence including deep venous thrombosis and pulmonary embolism |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ni Qihong, M.D. | Contact | +8615801900772 | niqihong1989@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ni Qihong, M.D. | Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| Percutaneous mechanical thrombectomy (PMT) by the traditional approach | Procedure | 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. |
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| Traditional approach | Procedure | 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. |
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Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)
| Immediately after interventional surgery |
| Total dosage of urokinase | Total dosage measured by units of urokinase used for procedure | Immediately after interventional surgery |
| Patency rate of lower limb vein | Percentage of patency rate of lower limb vein evaluated by ultrasound | 24-month |
| Incidence of post-thrombotic syndrome | Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score | 12-month |
| Re-intervention rate | Percentage of re-intervention rate for the same limb | 24-month |
| 24 months |
| All-cause death rate | All-cause death during the follow-up period | 24 months |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054070 | Postthrombotic Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014689 | Venous Insufficiency |
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