Trombectomía por aspiración utilizando el sistema Symphony o Prodigy (CLEAR-IT)
Evaluación CLínica a Largo Plazo de la Trombectomía por Aspiración Utilizando el Sistema de Trombectomía Symphony o ProdIgy - 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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sylvie Akiel-Fu, MPH
- Número de teléfono: 917-375-4735
- Correo electrónico: safu@imperativecare.com
Ubicaciones de estudio
-
-
Alabama
-
Huntsville, Alabama, Estados Unidos, 35801
- Reclutamiento
- Huntsville Hospital
-
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Florida
-
Clearwater, Florida, Estados Unidos, 33756
- Reclutamiento
- BayCare Health System- Morton Plant Hospital
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Jacksonville, Florida, Estados Unidos, 32216
- Reclutamiento
- HCA Florida Memorial Hospital
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Tampa, Florida, Estados Unidos, 33607
- Reclutamiento
- BayCare Health System - St. Joseph Hospital
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-
Illinois
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Naperville, Illinois, Estados Unidos, 60540
- Reclutamiento
- Midwest Cardiovascular Institute
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-
Indiana
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Munster, Indiana, Estados Unidos, 46321
- Reclutamiento
- Profound Research
-
-
Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Reclutamiento
- Henry Ford Hospital
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New York
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Buffalo, New York, Estados Unidos, 14203
- Reclutamiento
- University At Buffalo
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New York, New York, Estados Unidos, 10029
- Reclutamiento
- Mount Sinai Hospital
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27607
- Reclutamiento
- NC Heart and Vascular Research
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- Reclutamiento
- Mercy Health
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Texas
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Fort Worth, Texas, Estados Unidos, 761104
- Reclutamiento
- Medical City Fort Worth Hospital
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
- Reclutamiento
- Sentara Norfolk General Hospital
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peripheral Arterial Cohort
Periodo de tiempo: 30 days
|
Freedom from major (above-ankle) unanticipated amputation of the index limb |
30 days
|
|
Peripheral Venous Cohort
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peripheral Arterial Cohort
Periodo de tiempo: 90 Days
|
Freedom from major (above-ankle) amputation of the index limb |
90 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 180 Days
|
Freedom from major (above-ankle) amputation of the index limb |
180 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 30 Days
|
Major adverse cardiovascular events (MACE) rate |
30 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 90 Days
|
Major adverse cardiovascular events (MACE) rate |
90 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 180 Days
|
Major adverse cardiovascular events (MACE) rate |
180 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 30 Days
|
Target vessel patency assessed using change in ankle-brachial index |
30 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 90 Days
|
Target vessel patency assessed using change in ankle-brachial index |
90 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 180 Days
|
Target vessel patency assessed using change in ankle-brachial index |
180 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 30 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
30 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 90 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
90 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 180 Days
|
Target vessel patency assessed using change in Rutherford claudication grade |
180 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 90 Days
|
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) |
90 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 180 Days
|
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) |
180 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 30 Days
|
All-cause mortality |
30 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 90 Days
|
All-cause mortality |
90 Days
|
|
Peripheral Arterial Cohort
Periodo de tiempo: 180 Days
|
All-cause mortality |
180 Days
|
|
Peripheral Venous Cohort
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 90 Days
|
Proportion of patients demonstrating decrease in Villalta score |
90 Days
|
|
Peripheral Venous Cohort
Periodo de tiempo: 180 Days
|
Proportion of patients demonstrating decrease in Villalta score |
180 Days
|
|
Peripheral Venous Cohort
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 30 Days
|
All-cause mortality |
30 Days
|
|
Peripheral Venous Cohort
Periodo de tiempo: 90 Days
|
All-cause mortality |
90 Days
|
|
Peripheral Venous Cohort
Periodo de tiempo: 180 Days
|
All-cause mortality |
180 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: Intraprocedural
|
Change in pulmonary artery pressure |
Intraprocedural
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 48 hours
|
Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 48 hours
|
Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 30 Days
|
Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated |
30 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 48 hours
|
Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated |
48 hours
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 30 Days
|
Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated |
30 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 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
Periodo de tiempo: 30 days
|
Right ventricle to left ventricle (RV/LV) ratio reduction from baseline |
30 days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 90 Days
|
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class |
90 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 180 Days
|
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class |
180 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 30 Days
|
Pulmonary Embolism recurrence |
30 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 90 Days
|
Pulmonary Embolism recurrence |
90 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 180 Days
|
Pulmonary Embolism recurrence |
180 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 30 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
30 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 90 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
90 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 180 Days
|
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire |
180 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 30 Days
|
All-cause mortality |
30 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 90 Days
|
All-cause mortality |
90 Days
|
|
Pulmonary Embolism Cohort
Periodo de tiempo: 180 Days
|
All-cause mortality |
180 Days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Steven Abramowitz, MD, Medstar Health Research Institute
- Investigador principal: Maya Serhal, MD, Massachusetts General Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ICI-2025-002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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