- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07622212
Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis
26. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Antatt)
180
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Qihong Ni
- Telefonnummer: +8615801900772
- E-post: niqihong1989@163.com
Studiesteder
-
-
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Shanghai, Kina
- Rekruttering
- Renji Hospital
-
Ta kontakt med:
- Qihong Ni
- Telefonnummer: +8615801900772
- E-post: niqihong1989@163.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
180
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
ClotTriever System group
Patients receive 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
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of PTS
Tidsramme: At 24 months
|
Assessed by the Villalta score
|
At 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
|
Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
Tidsramme: at 6, 12, and 24 months
|
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
|
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
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at 24 months
|
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Rate of re-intervention
Tidsramme: at 24 months
|
Assessed by documentation of clinical reintervention
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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 |
Tiltaksbeskrivelse |
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
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at 24 months
|
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Incidence of symptomatic Venous Thromboembolism (VTE)
Tidsramme: at 24 months
|
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
|
All-cause death
|
at 24 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2024
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
26. mai 2026
Først innsendt som oppfylte QC-kriteriene
26. mai 2026
Først lagt ut (Faktiske)
3. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- The COMET Study
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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