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)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Qihong Ni
- Telefonnummer: +8615801900772
- E-mail: niqihong1989@163.com
Studiesteder
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Shanghai, Kina
- Rekruttering
- Renji Hospital
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Kontakt:
- Qihong Ni
- Telefonnummer: +8615801900772
- E-mail: niqihong1989@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Antal grupper/kohorter
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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ClotTriever System group
Patients receive percutaneous mechanical thrombectomy by ClotTriever System
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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.
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Aspiration thrombectomy group
Patients receive percutaneous mechanical thrombectomy by aspiration or rheolytic thrombectomy
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of PTS
Tidsramme: At 24 months
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Assessed by the Villalta score
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At 24 months
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of moderate-to-severe PTS
Tidsramme: at 6, 12, and 24 months
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Assessed by the Villalta score
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at 6, 12, and 24 months
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Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
Tidsramme: at 6, 12, and 24 months
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Based on clinical symptoms
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at 6, 12, and 24 months
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Patency rate of the ipsilateral iliofemoral vein
Tidsramme: at 12 months and 24 months
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Assessed by color Doppler ultrasound
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at 12 months and 24 months
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Incidence of PTS
Tidsramme: Assessed by the Villalta score
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at 6 and 12 months
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Assessed by the Villalta score
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Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)
Tidsramme: at 24 months
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Assessed by symptoms combined with ultrasound examination in the ipsilateral limb
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at 24 months
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Rate of re-intervention
Tidsramme: at 24 months
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Assessed by documentation of clinical reintervention
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at 24 months
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Quality of life score
Tidsramme: at 6, 12, and 24 months
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Assessed by Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire (VEINES-QOL)
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at 6, 12, and 24 months
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Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of major bleeding
Tidsramme: at 24 months
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Defined by International Society on Thrombosis and Haemostasis (ISTH) criteria
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at 24 months
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Incidence of symptomatic Pulmonary Embolism (PE)
Tidsramme: at 24 months
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Assessed by symptoms combined with contrast-enhanced computed tomography examination
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at 24 months
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Incidence of symptomatic Venous Thromboembolism (VTE)
Tidsramme: at 24 months
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Assessed by symptoms combined with ultrasound and contrast-enhanced computed tomography examination
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at 24 months
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All-cause mortality
Tidsramme: at 24 months
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All-cause death
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at 24 months
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- The COMET Study
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