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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis.
All patients presenting with symptoms in the lower extremity due to the femoral venous thrombosis involving or not involving iliac and popliteal veins treated with percutaneously pharmacomechanical catheter-directed thrombolysis via AngioJet devices or anticoagulation alone were included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacomechanical Catheter-directed Thrombolysis for acute DVT | Experimental | AngioJet, Boston Scientific |
|
| anticoagulation alone for acute DVT | Placebo Comparator | anticoagulation alone for acute DVT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AngioJet device | Device | A device can be used for thrombus aspiration and thrombolysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Valvular reflux prevalence | Proportion of patients with femoral venous valve reflux at 1 year after procedure | at 12 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) | Patients who experienced one of the following occurrences in the index leg between the 12 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaichuang Ye, MD, PhD | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuzhou People's Hospital | Chuzhou | Anhui | 238000 | China | ||
| Center hospital of Putu |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| anticoagulation alone | Other | a medicine for anticoagulation therapy |
|
|
| at 6, 12 and 24 months after procedure |
| Patency rate of femopopliteal vein and iliofemoral vein | Patients who presented with patent femopopliteal vein and iliofemoral vein | at 6, 12 and 24 months after procedure |
| Shanghai |
| Shanghai Municipality |
| 200011 |
| China |
| Central Hospital of Songjiang | Shanghai | Shanghai Municipality | 200011 | China |
| North Branch of Shanghai Ninth People's Hospital | Shanghai | Shanghai Municipality | 200011 | China |
| Shanghai Ninth People's Hospital | Shanghai | Shanghai Municipality | 200011 | China |
| Fengchen Hospital | Shanghai | Shanghai Municipality | 201400 | China |
| Taizhou Municipal hospital | Taizhou | Zhejiang | 218000 | China |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |