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| Name | Class |
|---|---|
| Changhai Hospital | OTHER |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
| Wenzhou Central Hospital | OTHER |
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A head-to-head comparison of two different types of percutaneous mechanical thrombectomy (PMT) - ClotTriever System versus aspiration thrombectomy (including rheolytic thrombectomy) - in patients with acute iliofemoral deep vein thrombosis (DVT) was conducted to determine whether ClotTriever System can improve thrombus clearance rate, reduce the incidence of post-thrombotic syndrome (PTS), and enhance the long-term efficacy of endovascular treatment for acute iliofemoral DVT.
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. There is currently a lack of research on which device is optimal for thrombus removal. The aim of this study is to conduct a multicenter, observational, prospective cohort study in patients with acute iliofemoral deep vein thrombosis (DVT), performing a head-to-head comparison of two different types of mechanical thrombectomy devices - ClotTriever System versus aspiration thrombectomy (including rheolytic thrombectomy) - to determine whether ClotTriever System can improve thrombus clearance rate, reduce the incidence of post-thrombotic syndrome (PTS), and enhance the long-term efficacy of endovascular treatment for acute iliofemoral DVT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ClotTriever System group | Patients receive percutaneous mechanical thrombectomy by ClotTriever System |
| |
| Aspiration thrombectomy group | Patients receive percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous mechanical thrombectomy by ClotTriever System | Procedure | The procedure is performed via the ipsilateral popliteal vein access or the ipsilateral femoral vein access. After puncture under fluoroscopic or ultrasound guidance, a vascular sheath is inserted, systemic heparinization is administered, and a guidewire is advanced antegradely into the inferior vena cava with the assistance of a catheter to establish the access. Once the access is established, treatment is carried out using stent retriever devices. Available stent retriever devices include currently marketed options such as ClotTriever (INARI MEDICAL, USA). After thrombectomy, the thrombus removal efficacy is assessed by venography. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of PTS | Assessed by the Villalta score | At 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of moderate-to-severe PTS | Assessed by the Villalta score | at 6, 12, and 24 months |
| Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP) | Based on clinical symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major bleeding | Defined by International Society on Thrombosis and Haemostasis (ISTH) criteria | at 24 months |
| Incidence of symptomatic Pulmonary Embolism (PE) | Assessed by symptoms combined with contrast-enhanced computed tomography examination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qihong Ni | Contact | +8615801900772 | niqihong1989@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji hospital | Recruiting | Shanghai | China |
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| West China Hospital |
| OTHER |
| Chengdu University of Traditional Chinese Medicine | OTHER |
| First People's Hospital of Hangzhou | OTHER |
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|
| Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy | Procedure | The procedure is performed via the ipsilateral calf deep vein access, the ipsilateral popliteal vein access, or the ipsilateral femoral vein access. After puncture under fluoroscopic or ultrasound guidance, a vascular sheath is inserted, systemic heparinization is administered, and a guidewire is advanced antegradely into the inferior vena cava with the assistance of a catheter to establish the access. Once the access is established, treatment is carried out using mechanical aspiration thrombectomy devices. Available aspiration thrombectomy devices include currently marketed options such as the AngioJet thrombectomy catheter (Boston Scientific, USA) and the Acostream thrombectomy catheter (Acotec, China). After thrombectomy, the thrombus removal efficacy is assessed by venography. |
|
| at 6, 12, and 24 months |
| Patency rate of the ipsilateral iliofemoral vein | Assessed by color Doppler ultrasound | at 12 months and 24 months |
| Incidence of PTS | at 6 and 12 months | Assessed by the Villalta score |
| Recurrence rate of symptomatic Deep Vein Thrombosis (DVT) | Assessed by symptoms combined with ultrasound examination in the ipsilateral limb | at 24 months |
| Rate of re-intervention | Assessed by documentation of clinical reintervention | at 24 months |
| Quality of life score | Assessed by Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire (VEINES-QOL) | at 6, 12, and 24 months |
| at 24 months |
| Incidence of symptomatic Venous Thromboembolism (VTE) | Assessed by symptoms combined with ultrasound and contrast-enhanced computed tomography examination | at 24 months |
| All-cause mortality | All-cause death | at 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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