Aspiraatiotrombektomia käyttäen Symphony- tai Prodigy-järjestelmää (CLEAR-IT)
Aspiraatiotrombektomian pitkäaikainen kliininen arviointi Symphony- tai ProdIgy-trombektomiajärjestelmällä - 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.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Sylvie Akiel-Fu, MPH
- Puhelinnumero: 917-375-4735
- Sähköposti: safu@imperativecare.com
Opiskelupaikat
-
-
Alabama
-
Huntsville, Alabama, Yhdysvallat, 35801
- Rekrytointi
- Huntsville Hospital
-
-
Florida
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Clearwater, Florida, Yhdysvallat, 33756
- Rekrytointi
- BayCare Health System- Morton Plant Hospital
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Jacksonville, Florida, Yhdysvallat, 32216
- Rekrytointi
- HCA Florida Memorial Hospital
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Tampa, Florida, Yhdysvallat, 33607
- Rekrytointi
- BayCare Health System - St. Joseph Hospital
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-
Illinois
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Naperville, Illinois, Yhdysvallat, 60540
- Rekrytointi
- Midwest Cardiovascular Institute
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Indiana
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Munster, Indiana, Yhdysvallat, 46321
- Rekrytointi
- Profound Research
-
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Michigan
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Detroit, Michigan, Yhdysvallat, 48202
- Rekrytointi
- Henry Ford Hospital
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New York
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Buffalo, New York, Yhdysvallat, 14203
- Rekrytointi
- University At Buffalo
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New York, New York, Yhdysvallat, 10029
- Rekrytointi
- Mount Sinai Hospital
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North Carolina
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Raleigh, North Carolina, Yhdysvallat, 27607
- Rekrytointi
- NC Heart and Vascular Research
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Ohio
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Cincinnati, Ohio, Yhdysvallat, 45242
- Rekrytointi
- Mercy Health
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Texas
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Fort Worth, Texas, Yhdysvallat, 761104
- Rekrytointi
- Medical City Fort Worth Hospital
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Virginia
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Norfolk, Virginia, Yhdysvallat, 23502
- Rekrytointi
- Sentara Norfolk General Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
Inclusion Criteria:
- Subject is ≥ 18 years of age
- Subject is willing and able to comply with the follow-up schedule specified in this protocol
- Subject is willing and able to provide written informed consent prior to any study-related data collection
- Subject has a planned procedure, involving the use of Imperative Care vascular devices within their intended use
Exclusion Criteria:
- Subjects with any contraindications per the applicable Instructions for Use
- Subject with life expectancy of less than 1 year
- In the opinion of the Investigator, the patient is not a suitable candidate for intervention with Imperative Care devices
- Subject who may be unable to complete study follow-up
- Peripheral Venous Cohort ONLY: Presence of thrombus extending more than 2 cm into the IVC on imaging
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
Peripheral Arterial
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature |
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 |
Removal of thrombus/emboli from blood vessels in the peripheral vasculature 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 |
Removal of thrombus/emboli from blood vessels in the peripheral vasculature Removal of thrombus/emboli from the pulmonary vasculature |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Peripheral Arterial Cohort
Aikaikkuna: 30 days
|
Freedom from major (above-ankle) unanticipated amputation of the index limb |
30 days
|
|
Peripheral Venous Cohort
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Peripheral Arterial Cohort
Aikaikkuna: 90 Days
|
Freedom from major (above-ankle) amputation of the index limb |
90 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 180 Days
|
Freedom from major (above-ankle) amputation of the index limb |
180 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 30 Days
|
Major adverse cardiovascular events (MACE) rate |
30 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 90 Days
|
Major adverse cardiovascular events (MACE) rate |
90 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 180 Days
|
Major adverse cardiovascular events (MACE) rate |
180 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 30 Days
|
Target vessel patency assessed using change in ankle-brachial index |
30 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 90 Days
|
Target vessel patency assessed using change in ankle-brachial index |
90 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 180 Days
|
Target vessel patency assessed using change in ankle-brachial index |
180 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 30 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
30 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 90 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
90 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 180 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
180 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 90 Days
|
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) |
90 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 180 Days
|
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) |
180 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 30 Days
|
All-cause mortality |
30 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 90 Days
|
All-cause mortality |
90 Days
|
|
Peripheral Arterial Cohort
Aikaikkuna: 180 Days
|
All-cause mortality |
180 Days
|
|
Peripheral Venous Cohort
Aikaikkuna: 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
Aikaikkuna: 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:
|
48 hours
|
|
Peripheral Venous Cohort
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 90 Days
|
Proportion of patients demonstrating decrease in Villalta score |
90 Days
|
|
Peripheral Venous Cohort
Aikaikkuna: 180 Days
|
Proportion of patients demonstrating decrease in Villalta score |
180 Days
|
|
Peripheral Venous Cohort
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 30 Days
|
All-cause mortality |
30 Days
|
|
Peripheral Venous Cohort
Aikaikkuna: 90 Days
|
All-cause mortality |
90 Days
|
|
Peripheral Venous Cohort
Aikaikkuna: 180 Days
|
All-cause mortality |
180 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: Intraprocedural
|
Change in pulmonary artery pressure |
Intraprocedural
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 48 hours
|
Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 48 hours
|
Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 30 Days
|
Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated |
30 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 48 hours
|
Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 30 Days
|
Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated |
30 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 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:
|
48 hours
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 30 days
|
Right ventricle to left ventricle (RV/LV) ratio reduction from baseline |
30 days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 90 Days
|
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class |
90 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 180 Days
|
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class |
180 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 30 Days
|
Pulmonary Embolism recurrence |
30 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 90 Days
|
Pulmonary Embolism recurrence |
90 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 180 Days
|
Pulmonary Embolism recurrence |
180 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 30 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
30 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 90 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
90 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 180 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
180 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 30 Days
|
All-cause mortality |
30 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 90 Days
|
All-cause mortality |
90 Days
|
|
Pulmonary Embolism Cohort
Aikaikkuna: 180 Days
|
All-cause mortality |
180 Days
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Steven Abramowitz, MD, Medstar Health Research Institute
- Päätutkija: Maya Serhal, MD, Massachusetts General Hospital
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
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Avainsanat
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