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)
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Qihong Ni
- Telefonnummer: +8615801900772
- E-Mail: niqihong1989@163.com
Studienorte
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Shanghai, China
- Rekrutierung
- Renji Hospital
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Kontakt:
- Qihong Ni
- Telefonnummer: +8615801900772
- E-Mail: niqihong1989@163.com
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Anzahl der Gruppen / Kohorten
Kohorten und Interventionen
Gruppe / KohorteGruppe / Kohorte |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of PTS
Zeitfenster: At 24 months
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Assessed by the Villalta score
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At 24 months
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of moderate-to-severe PTS
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of major bleeding
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: at 24 months
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All-cause death
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at 24 months
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- The COMET Study
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