Deep Vein Thrombosis
Conditions
Keywords
Deep venous thrombosis, Percutaneous mechanical thrombectomy, Post-thrombotic syndrome
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPercutaneous mechanical thrombectomy by ClotTriever System
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.
PROCEDUREPercutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy
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.
Sponsors
RenJi Hospital
Changhai Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Wenzhou Central Hospital
West China Hospital
Chengdu University of Traditional Chinese Medicine
First People's Hospital of Hangzhou
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 85 years; 2. Diagnosed with acute iliofemoral venous thrombosis, with thrombosis involving at least the iliac vein and common femoral vein; 3. Time from symptom onset to endovascular treatment ≤ 14 days; 4. Patients undergo endovascular treatment with percutaneous mechanical thrombectomy; 5. Patients sign the informed consent form.
Exclusion criteria
1. Presence of PTS in the limb to be treated in this procedure, or a history of symptomatic DVT in the same limb within the past 2 years; 2. Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb; 3. Known allergy to heparin, low molecular weight heparin, contrast agents, etc. 4. Concomitant severe pulmonary embolism with hemodynamic changes, such as hypoxia, hypotension, etc. 5. Inability to tolerate endovascular treatment due to conditions such as acute systemic illness, severe dyspnea, etc. 6. Concomitant severe renal insufficiency with creatinine clearance \< 30 ml/min; 7. Concomitant active bleeding, severe hepatic insufficiency, bleeding tendency, etc. 8. Concomitant severe anemia (hemoglobin \< 8.0 mg/dL) or platelet count \< 80,000/mL; 9. History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm; 10. Pregnant women; 11. Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency, etc.) with an expected life expectancy \< 24 months 12. Participation in any drug or medical device clinical trial that may interfere with this study within the past 1 month; 13. Patients unwilling to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PTS | At 24 months | Assessed by the Villalta score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of moderate-to-severe PTS | at 6, 12, and 24 months | Assessed by the Villalta score |
| Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP) | at 6, 12, and 24 months | Based on clinical symptoms |
| Patency rate of the ipsilateral iliofemoral vein | at 12 months and 24 months | Assessed by color Doppler ultrasound |
| Incidence of PTS | Assessed by the Villalta score | at 6 and 12 months |
| Recurrence rate of symptomatic Deep Vein Thrombosis (DVT) | at 24 months | Assessed by symptoms combined with ultrasound examination in the ipsilateral limb |
| Rate of re-intervention | at 24 months | Assessed by documentation of clinical reintervention |
| Quality of life score | at 6, 12, and 24 months | Assessed by Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire (VEINES-QOL) |
Countries
China
Contacts
CONTACTQihong Ni
Outcome results
None listed