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.
Study Type
OBSERVATIONAL
Enrollment
750
Removal of thrombus/emboli from blood vessels in the peripheral vasculature
Removal of thrombus/emboli from blood vessels in the peripheral vasculature
Removal of thrombus/emboli from the pulmonary vasculature
Huntsville Hospital
Huntsville, Alabama, United States
RECRUITINGBayCare Health - St. Joseph Hospital
Tampa, Florida, United States
RECRUITINGMidwest Cardiovascular Institute
Naperville, Illinois, United States
Peripheral Arterial Cohort
Freedom from major (above-ankle) unanticipated amputation of the index limb
Time frame: 30 days
Peripheral Venous Cohort
Treated limb improvement at 30 days, defined as no unplanned intervention for breakthrough re-thrombosis and improvement in Villalta score relative to baseline.
Time frame: 30 days
Pulmonary Embolism (PE) Cohort
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.
Time frame: 30 Days
Peripheral Arterial Cohort
Freedom from major (above-ankle) amputation of the index limb
Time frame: 90 Days
Peripheral Arterial Cohort
Freedom from major (above-ankle) amputation of the index limb
Time frame: 180 Days
Peripheral Arterial Cohort
Major adverse cardiovascular events (MACE) rate
Time frame: 30 Days
Peripheral Arterial Cohort
Major adverse cardiovascular events (MACE) rate
Time frame: 90 Days
Peripheral Arterial Cohort
Major adverse cardiovascular events (MACE) rate
Time frame: 180 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Profound Research
Munster, Indiana, United States
RECRUITINGUniversity At Buffalo
Buffalo, New York, United States
RECRUITINGMount Sinai Hospital
New York, New York, United States
RECRUITINGMercy Health
Cincinnati, Ohio, United States
RECRUITINGSentara Norfolk General Hospital
Norfolk, Virginia, United States
RECRUITINGPeripheral Arterial Cohort
Target vessel patency assessed using change in ankle-brachial index
Time frame: 30 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in ankle-brachial index
Time frame: 90 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in ankle-brachial index
Time frame: 180 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in Rutherford claudication grade
Time frame: 30 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in Rutherford claudication grade
Time frame: 90 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in Rutherford claudication grade
Time frame: 180 Days
Peripheral Arterial Cohort
Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management
Time frame: 30 Days
Peripheral Arterial Cohort
Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management
Time frame: 90 Days
Peripheral Arterial Cohort
Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management
Time frame: 180 Days
Peripheral Arterial Cohort
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)
Time frame: 90 Days
Peripheral Arterial Cohort
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)
Time frame: 180 Days
Peripheral Arterial Cohort
All-cause mortality
Time frame: 30 Days
Peripheral Arterial Cohort
All-cause mortality
Time frame: 90 Days
Peripheral Arterial Cohort
All-cause mortality
Time frame: 180 Days
Peripheral Venous Cohort
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
Time frame: Intraprocedural
Peripheral Venous Cohort
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)
Time frame: 48 hours
Peripheral Venous Cohort
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
Time frame: 90
Peripheral Venous Cohort
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
Time frame: 180
Peripheral Venous Cohort
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)
Time frame: 30 Days
Peripheral Venous Cohort
Proportion of patients demonstrating decrease in Villalta score
Time frame: 90 Days
Peripheral Venous Cohort
Proportion of patients demonstrating decrease in Villalta score
Time frame: 180 Days
Peripheral Venous Cohort
Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure.
Time frame: 30 Days
Peripheral Venous Cohort
Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure.
Time frame: 60 Days
Peripheral Venous Cohort
Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure.
Time frame: 180 Days
Peripheral Venous Cohort
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
Time frame: 180 Days
Peripheral Venous Cohort
All-cause mortality
Time frame: 30 Days
Peripheral Venous Cohort
All-cause mortality
Time frame: 90 Days
Peripheral Venous Cohort
All-cause mortality
Time frame: 180 Days
Pulmonary Embolism Cohort
Change in pulmonary artery pressure
Time frame: Intraprocedural
Pulmonary Embolism Cohort
Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated
Time frame: 48 hours
Pulmonary Embolism Cohort
Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated
Time frame: 48 hours
Pulmonary Embolism Cohort
Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated
Time frame: 30 Days
Pulmonary Embolism Cohort
Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated
Time frame: 48 hours
Pulmonary Embolism Cohort
Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated
Time frame: 30 Days
Pulmonary Embolism Cohort
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)
Time frame: 48 hours
Pulmonary Embolism Cohort
Right ventricle to left ventricle (RV/LV) ratio reduction from baseline
Time frame: 30 days
Pulmonary Embolism Cohort
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class
Time frame: 90 Days
Pulmonary Embolism Cohort
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class
Time frame: 180 Days
Pulmonary Embolism Cohort
Pulmonary Embolism recurrence
Time frame: 30 Days
Pulmonary Embolism Cohort
Pulmonary Embolism recurrence
Time frame: 90 Days
Pulmonary Embolism Cohort
Pulmonary Embolism recurrence
Time frame: 180 Days
Pulmonary Embolism Cohort
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
Time frame: 30 Days
Pulmonary Embolism Cohort
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
Time frame: 90 Days
Pulmonary Embolism Cohort
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
Time frame: 180 Days
Pulmonary Embolism Cohort
All-cause mortality
Time frame: 30 Days
Pulmonary Embolism Cohort
All-cause mortality
Time frame: 90 Days
Pulmonary Embolism Cohort
All-cause mortality
Time frame: 180 Days