RecruitingNCT07622212

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

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

Sponsor

RenJi Hospital

Enrollment

180 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Deep Vein Thrombosis

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

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 Criteria13

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.

Interested in this trial?

Get notified about updates and connect with the research team.

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.