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

26. maj 2026 opdateret af: RenJi Hospital

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

180

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Shanghai, Kina
        • Rekruttering
        • Renji Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

180

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
ClotTriever System group
Patients receive percutaneous mechanical thrombectomy by ClotTriever System
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 currently marketed options such as ClotTriever (INARI MEDICAL, USA). After thrombectomy, the thrombus removal efficacy is assessed by venography.
Aspiration thrombectomy group
Patients receive percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy
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 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of PTS
Tidsramme: At 24 months
Assessed by the Villalta score
At 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of moderate-to-severe PTS
Tidsramme: at 6, 12, and 24 months
Assessed by the Villalta score
at 6, 12, and 24 months
Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
Tidsramme: at 6, 12, and 24 months
Based on clinical symptoms
at 6, 12, and 24 months
Patency rate of the ipsilateral iliofemoral vein
Tidsramme: at 12 months and 24 months
Assessed by color Doppler ultrasound
at 12 months and 24 months
Incidence of PTS
Tidsramme: Assessed by the Villalta score
at 6 and 12 months
Assessed by the Villalta score
Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)
Tidsramme: at 24 months
Assessed by symptoms combined with ultrasound examination in the ipsilateral limb
at 24 months
Rate of re-intervention
Tidsramme: at 24 months
Assessed by documentation of clinical reintervention
at 24 months
Quality of life score
Tidsramme: at 6, 12, and 24 months
Assessed by Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire (VEINES-QOL)
at 6, 12, and 24 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of major bleeding
Tidsramme: at 24 months
Defined by International Society on Thrombosis and Haemostasis (ISTH) criteria
at 24 months
Incidence of symptomatic Pulmonary Embolism (PE)
Tidsramme: at 24 months
Assessed by symptoms combined with contrast-enhanced computed tomography examination
at 24 months
Incidence of symptomatic Venous Thromboembolism (VTE)
Tidsramme: at 24 months
Assessed by symptoms combined with ultrasound and contrast-enhanced computed tomography examination
at 24 months
All-cause mortality
Tidsramme: at 24 months
All-cause death
at 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

RenJi Hospital

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2024

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • The COMET Study

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