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Aspirasjonstrombektomi ved bruk av Symphony- eller Prodigy-systemet (CLEAR-IT)

20. oktober 2026 oppdatert av: Imperative Care, Inc.

Langtidsperspektiv Klinisk Evaluering av Aspirasjons Trombektomi ved bruk av Symphony eller ProdIgy Trombektomisystemet - 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

750

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Peripheral Arterial

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

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

Enhet: 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
Enhet: Symphony Thrombectomy System

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

Enhet: Symphony Thrombectomy System

Removal of thrombus/emboli from the pulmonary vasculature

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peripheral Arterial Cohort
Tidsramme: 30 days

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peripheral Arterial Cohort
Tidsramme: 90 Days

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

All-cause mortality
180 Days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Imperative Care, Inc.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. februar 2026

Primær fullføring (Antatt)

1. mars 2030

Studiet fullført (Antatt)

1. september 2030

Datoer for studieregistrering

Først innsendt

21. november 2025

Først innsendt som oppfylte QC-kriteriene

10. januar 2026

Først lagt ut (Faktiske)

20. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ICI-2025-002

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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