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Aspiratie-trombectomie met het Symphony- of Prodigy-systeem (CLEAR-IT)

20 oktober 2026 bijgewerkt door: Imperative Care, Inc.

Langdurige klinische evaluatie van aspiratietrombectomie met het Symphony- of ProdIgy-trombectomiesysteem - 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

750

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Peripheral Arterial

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

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

Apparaat: 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
Apparaat: Symphony Thrombectomy System

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

Apparaat: Symphony Thrombectomy System

Removal of thrombus/emboli from the pulmonary vasculature

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Peripheral Arterial Cohort
Tijdsspanne: 30 days

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Peripheral Arterial Cohort
Tijdsspanne: 90 Days

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

All-cause mortality
180 Days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Imperative Care, Inc.

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 februari 2026

Primaire voltooiing (Geschat)

1 maart 2030

Studie voltooiing (Geschat)

1 september 2030

Studieregistratiedata

Eerst ingediend

21 november 2025

Eerst ingediend dat voldeed aan de QC-criteria

10 januari 2026

Eerst geplaatst (Werkelijk)

20 januari 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

20 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ICI-2025-002

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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