Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis

Official title

Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis (The COMET Study)

Overview

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

• Procedure Percutaneous 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 curr
• Procedure Percutaneous 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 thrombect

Primary outcome measures

• Incidence of PTS [Time frame: At 24 months]

Secondary outcome measures (7)

• Incidence of moderate-to-severe PTS [Time frame: at 6, 12, and 24 months]
• Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP) [Time frame: at 6, 12, and 24 months]
• Patency rate of the ipsilateral iliofemoral vein [Time frame: at 12 months and 24 months]
• Incidence of PTS [Time frame: Assessed by the Villalta score]
• Recurrence rate of symptomatic Deep Vein Thrombosis (DVT) [Time frame: at 24 months]
• Rate of re-intervention [Time frame: at 24 months]
• Quality of life score [Time frame: at 6, 12, and 24 months]

Eligibility criteria

Inclusion criteria

• Aged between 18 and 85 years;
• Diagnosed with acute iliofemoral venous thrombosis, with thrombosis involving at least the iliac vein and common femoral vein;
• Time from symptom onset to endovascular treatment ≤ 14 days;
• Patients undergo endovascular treatment with percutaneous mechanical thrombectomy;
• Patients sign the informed consent form.

Exclusion criteria

• 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;
• Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;
• Known allergy to heparin, low molecular weight heparin, contrast agents, etc.
• Concomitant severe pulmonary embolism with hemodynamic changes, such as hypoxia, hypotension, etc.
• Inability to tolerate endovascular treatment due to conditions such as acute systemic illness, severe dyspnea, etc.
• Concomitant severe renal insufficiency with creatinine clearance < 30 ml/min;
• Concomitant active bleeding, severe hepatic insufficiency, bleeding tendency, etc.
• Concomitant severe anemia (hemoglobin < 8.0 mg/dL) or platelet count < 80,000/mL;
• History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm;
• Pregnant women;
• Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency, etc.) with an expected life expectancy < 24 months
• Participation in any drug or medical device clinical trial that may interfere with this study within the past 1 month;
• Patients unwilling to participate in this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Renji hospital — Shanghai

Identifiers

NCT: NCT07622212 · The COMET Study

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗