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NCT Number: NCT07622212

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of PTS

    Time frame: At 24 months

    Assessed by the Villalta score

Secondary outcomes

  1. Incidence of moderate-to-severe PTS

    Time frame: at 6, 12, and 24 months

    Assessed by the Villalta score

  2. Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP)

    Time frame: at 6, 12, and 24 months

    Based on clinical symptoms

  3. Patency rate of the ipsilateral iliofemoral vein

    Time frame: at 12 months and 24 months

    Assessed by color Doppler ultrasound

  4. Incidence of PTS

    Time frame: Assessed by the Villalta score

    at 6 and 12 months

  5. Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)

    Time frame: at 24 months

    Assessed by symptoms combined with ultrasound examination in the ipsilateral limb

  6. Rate of re-intervention

    Time frame: at 24 months

    Assessed by documentation of clinical reintervention

  7. Quality of life score

    Time frame: at 6, 12, and 24 months

    Assessed by Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire (VEINES-QOL)

Other outcomes

  1. Incidence of major bleeding

    Time frame: at 24 months

    Defined by International Society on Thrombosis and Haemostasis (ISTH) criteria

  2. Incidence of symptomatic Pulmonary Embolism (PE)

    Time frame: at 24 months

    Assessed by symptoms combined with contrast-enhanced computed tomography examination

  3. Incidence of symptomatic Venous Thromboembolism (VTE)

    Time frame: at 24 months

    Assessed by symptoms combined with ultrasound and contrast-enhanced computed tomography examination

  4. All-cause mortality

    Time frame: at 24 months

    All-cause death

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Changhai Hospital
  • Chengdu University of Traditional Chinese Medicine
  • First People's Hospital of Hangzhou
  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
  • Wenzhou Central Hospital
  • West China Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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