Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Aspirations-Thrombektomie mit dem Symphony- oder Prodigy-System (CLEAR-IT)

20. Oktober 2026 aktualisiert von: Imperative Care, Inc.

Langzeit-KLInische Bewertung der Aspirations-Thrombektomie mit dem Symphony oder ProdIgy Thrombektomie-System - CLEAR-IT

The study is designed to evaluate the short-term and long-term clinical performance and safety of the Symphony and Prodigy thrombectomy systems used in endovascular procedures across the peripheral or pulmonary vasculature.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

750

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Huntsville, Alabama, Vereinigte Staaten, 35801
        • Rekrutierung
        • Huntsville Hospital
    • Florida
      • Clearwater, Florida, Vereinigte Staaten, 33756
        • Rekrutierung
        • BayCare Health System- Morton Plant Hospital
      • Jacksonville, Florida, Vereinigte Staaten, 32216
        • Rekrutierung
        • HCA Florida Memorial Hospital
      • Tampa, Florida, Vereinigte Staaten, 33607
        • Rekrutierung
        • BayCare Health System - St. Joseph Hospital
    • Illinois
      • Naperville, Illinois, Vereinigte Staaten, 60540
        • Rekrutierung
        • Midwest Cardiovascular Institute
    • Indiana
      • Munster, Indiana, Vereinigte Staaten, 46321
        • Rekrutierung
        • Profound Research
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Rekrutierung
        • Henry Ford Hospital
    • New York
      • Buffalo, New York, Vereinigte Staaten, 14203
        • Rekrutierung
        • University At Buffalo
      • New York, New York, Vereinigte Staaten, 10029
        • Rekrutierung
        • Mount Sinai Hospital
    • North Carolina
      • Raleigh, North Carolina, Vereinigte Staaten, 27607
        • Rekrutierung
        • NC Heart and Vascular Research
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45242
        • Rekrutierung
        • Mercy Health
    • Texas
      • Fort Worth, Texas, Vereinigte Staaten, 761104
        • Rekrutierung
        • Medical City Fort Worth Hospital
    • Virginia
      • Norfolk, Virginia, Vereinigte Staaten, 23502
        • Rekrutierung
        • Sentara Norfolk General Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

The study will enroll subjects aged 18 years and older who are undergoing endovascular procedures in the peripheral or pulmonary vasculature systems where, in the opinion of the treating physician, Imperative Care devices are appropriate for use within their cleared indications. All subjects must meet the general eligibility criteria and provide written informed consent prior to any study-specific data collection.

Beschreibung

Inclusion Criteria:

  1. Subject is ≥ 18 years of age
  2. Subject is willing and able to comply with the follow-up schedule specified in this protocol
  3. Subject is willing and able to provide written informed consent prior to any study-related data collection
  4. Subject has a planned procedure, involving the use of Imperative Care vascular devices within their intended use

Exclusion Criteria:

  1. Subjects with any contraindications per the applicable Instructions for Use
  2. Subject with life expectancy of less than 1 year
  3. In the opinion of the Investigator, the patient is not a suitable candidate for intervention with Imperative Care devices
  4. Subject who may be unable to complete study follow-up
  5. Peripheral Venous Cohort ONLY: Presence of thrombus extending more than 2 cm into the IVC on imaging

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Peripheral Arterial

Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature
Gerät: Prodigy Thrombectomy System

Removal of thrombus/emboli from blood vessels in the peripheral vasculature
Peripheral Venous

Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral venous vasculature
Gerät: Symphony Thrombectomy System

Removal of thrombus/emboli from blood vessels in the peripheral vasculature

Gerät: Symphony Thrombectomy System

Removal of thrombus/emboli from the pulmonary vasculature
Pulmonary Embolism

Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the pulmonary vasculature
Gerät: Symphony Thrombectomy System

Removal of thrombus/emboli from blood vessels in the peripheral vasculature

Gerät: Symphony Thrombectomy System

Removal of thrombus/emboli from the pulmonary vasculature

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peripheral Arterial Cohort
Zeitfenster: 30 days

Freedom from major (above-ankle) unanticipated amputation of the index limb
30 days
Peripheral Venous Cohort
Zeitfenster: 30 days

Treated limb improvement at 30 days, defined as no unplanned intervention for breakthrough re-thrombosis and improvement in Villalta score relative to baseline.
30 days
Pulmonary Embolism (PE) Cohort
Zeitfenster: 30 Days

Normal right ventricular function at 30 days follow-up, defined as tricuspid annular plane systolic excursion (TAPSE) >1.7cm , measured on transthoracic echocardiography (TTE) and independently adjudicated.
30 Days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peripheral Arterial Cohort
Zeitfenster: 90 Days

Freedom from major (above-ankle) amputation of the index limb
90 Days
Peripheral Arterial Cohort
Zeitfenster: 180 Days

Freedom from major (above-ankle) amputation of the index limb
180 Days
Peripheral Arterial Cohort
Zeitfenster: 30 Days

Major adverse cardiovascular events (MACE) rate
30 Days
Peripheral Arterial Cohort
Zeitfenster: 90 Days

Major adverse cardiovascular events (MACE) rate
90 Days
Peripheral Arterial Cohort
Zeitfenster: 180 Days

Major adverse cardiovascular events (MACE) rate
180 Days
Peripheral Arterial Cohort
Zeitfenster: 30 Days

Target vessel patency assessed using change in ankle-brachial index
30 Days
Peripheral Arterial Cohort
Zeitfenster: 90 Days

Target vessel patency assessed using change in ankle-brachial index
90 Days
Peripheral Arterial Cohort
Zeitfenster: 180 Days

Target vessel patency assessed using change in ankle-brachial index
180 Days
Peripheral Arterial Cohort
Zeitfenster: 30 Days

Target vessel patency assessed using change in Rutherford claudication grade
30 Days
Peripheral Arterial Cohort
Zeitfenster: 90 Days

Target vessel patency assessed using change in Rutherford claudication grade
90 Days
Peripheral Arterial Cohort
Zeitfenster: 180 Days

Target vessel patency assessed using change in Rutherford claudication grade
180 Days
Peripheral Arterial Cohort
Zeitfenster: 30 Days

Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management
30 Days
Peripheral Arterial Cohort
Zeitfenster: 90 Days

Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management
90 Days
Peripheral Arterial Cohort
Zeitfenster: 180 Days

Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management
180 Days
Peripheral Arterial Cohort
Zeitfenster: 90 Days

Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)
90 Days
Peripheral Arterial Cohort
Zeitfenster: 180 Days

Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)
180 Days
Peripheral Arterial Cohort
Zeitfenster: 30 Days

All-cause mortality
30 Days
Peripheral Arterial Cohort
Zeitfenster: 90 Days

All-cause mortality
90 Days
Peripheral Arterial Cohort
Zeitfenster: 180 Days

All-cause mortality
180 Days
Peripheral Venous Cohort
Zeitfenster: Intraprocedural

Technical success defined as complete or near complete (>75%) reduction in Marder score from baseline to immediately after the use of the device and prior to any use of adjunctive device, as independently adjudicated
Intraprocedural
Peripheral Venous Cohort
Zeitfenster: 48 hours

Rate of Major Adverse Events (MAEs) as adjudicated by an independent medical monitor and defined as the occurrence of any of the following:

  • Major bleeding
  • Device-related mortality
  • Device-related Serious Adverse Events (SAE)
48 hours
Peripheral Venous Cohort
Zeitfenster: 90

Treated limb improvement at 90 days, defined as no unplanned intervention for re-thrombosis in patients who are compliant with prescribed medical management and improvement in Villalta score relative to baseline
90
Peripheral Venous Cohort
Zeitfenster: 180

Treated limb improvement at 180 days, defined as no unplanned intervention for re-thrombosis in patients who are compliant with prescribed medical management and improvement in Villalta score relative to baseline
180
Peripheral Venous Cohort
Zeitfenster: 30 Days

Proportion of patients demonstrating decrease in Villalta score (A decrease in Villalta score reflects an improvement per the following scale: 0-4 - no disease; 5-9: mild disease; 10-14: moderate disease; 15 or > : severe disease)
30 Days
Peripheral Venous Cohort
Zeitfenster: 90 Days

Proportion of patients demonstrating decrease in Villalta score
90 Days
Peripheral Venous Cohort
Zeitfenster: 180 Days

Proportion of patients demonstrating decrease in Villalta score
180 Days
Peripheral Venous Cohort
Zeitfenster: 30 Days

Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure.
30 Days
Peripheral Venous Cohort
Zeitfenster: 60 Days

Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure.
60 Days
Peripheral Venous Cohort
Zeitfenster: 180 Days

Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure.
180 Days
Peripheral Venous Cohort
Zeitfenster: 180 Days

Quality of life and symptom severity assessment using the Venous Insufficiency Epidemiological and Economic Study (VEINES -QOL); higher scores indicate better quality of life/fewer symptoms
180 Days
Peripheral Venous Cohort
Zeitfenster: 30 Days

All-cause mortality
30 Days
Peripheral Venous Cohort
Zeitfenster: 90 Days

All-cause mortality
90 Days
Peripheral Venous Cohort
Zeitfenster: 180 Days

All-cause mortality
180 Days
Pulmonary Embolism Cohort
Zeitfenster: Intraprocedural

Change in pulmonary artery pressure
Intraprocedural
Pulmonary Embolism Cohort
Zeitfenster: 48 hours

Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated
48 hours
Pulmonary Embolism Cohort
Zeitfenster: 48 hours

Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated
48 hours
Pulmonary Embolism Cohort
Zeitfenster: 30 Days

Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated
30 Days
Pulmonary Embolism Cohort
Zeitfenster: 48 hours

Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated
48 hours
Pulmonary Embolism Cohort
Zeitfenster: 30 Days

Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated
30 Days
Pulmonary Embolism Cohort
Zeitfenster: 48 hours

Rate of Major Adverse Events (MAEs) as adjudicated by an independent medical monitor and defined as the occurrence of any of the following:

  • Major bleeding
  • Device-related mortality
  • Device-related Serious Adverse Events (SAE)
48 hours
Pulmonary Embolism Cohort
Zeitfenster: 30 days

Right ventricle to left ventricle (RV/LV) ratio reduction from baseline
30 days
Pulmonary Embolism Cohort
Zeitfenster: 90 Days

Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class
90 Days
Pulmonary Embolism Cohort
Zeitfenster: 180 Days

Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class
180 Days
Pulmonary Embolism Cohort
Zeitfenster: 30 Days

Pulmonary Embolism recurrence
30 Days
Pulmonary Embolism Cohort
Zeitfenster: 90 Days

Pulmonary Embolism recurrence
90 Days
Pulmonary Embolism Cohort
Zeitfenster: 180 Days

Pulmonary Embolism recurrence
180 Days
Pulmonary Embolism Cohort
Zeitfenster: 30 Days

Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
30 Days
Pulmonary Embolism Cohort
Zeitfenster: 90 Days

Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
90 Days
Pulmonary Embolism Cohort
Zeitfenster: 180 Days

Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
180 Days
Pulmonary Embolism Cohort
Zeitfenster: 30 Days

All-cause mortality
30 Days
Pulmonary Embolism Cohort
Zeitfenster: 90 Days

All-cause mortality
90 Days
Pulmonary Embolism Cohort
Zeitfenster: 180 Days

All-cause mortality
180 Days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Imperative Care, Inc.

Ermittler

  • Hauptermittler: Steven Abramowitz, MD, Medstar Health Research Institute
  • Hauptermittler: Maya Serhal, MD, Massachusetts General Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Februar 2026

Primärer Abschluss (Geschätzt)

1. März 2030

Studienabschluss (Geschätzt)

1. September 2030

Studienanmeldedaten

Zuerst eingereicht

21. November 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Januar 2026

Zuerst gepostet (Tatsächlich)

20. Januar 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ICI-2025-002

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren