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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Percutaneous mechanical thrombectomy by ClotTriever System and a procedure called Percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy for people with deep vein thrombosis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.