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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral Arterial | Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature |
| |
| Peripheral Venous | Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral venous vasculature |
| |
| Pulmonary Embolism | Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the pulmonary vasculature |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prodigy Thrombectomy System | Device | Removal of thrombus/emboli from blood vessels in the peripheral vasculature |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Arterial Cohort | Freedom from major (above-ankle) unanticipated amputation of the index limb | 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. | 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. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Arterial Cohort | Freedom from major (above-ankle) amputation of the index limb | 90 Days |
| Peripheral Arterial Cohort | Freedom from major (above-ankle) amputation of the index limb |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvie Akiel-Fu, MPH | Contact | 917-375-4735 | safu@imperativecare.com |
| Name | Affiliation | Role |
|---|---|---|
| Steven Abramowitz, MD | Medstar Health Research Institute | Principal Investigator |
| Maya Serhal, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville Hospital | Recruiting | Huntsville | Alabama | 35801 | United States | |
| BayCare Health - St. Joseph Hospital |
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| Symphony Thrombectomy System | Device | Removal of thrombus/emboli from blood vessels in the peripheral vasculature |
|
| Symphony Thrombectomy System | Device | Removal of thrombus/emboli from the pulmonary vasculature |
|
| 180 Days |
| Peripheral Arterial Cohort | Major adverse cardiovascular events (MACE) rate | 30 Days |
| Peripheral Arterial Cohort | Major adverse cardiovascular events (MACE) rate | 90 Days |
| Peripheral Arterial Cohort | Major adverse cardiovascular events (MACE) rate | 180 Days |
| Peripheral Arterial Cohort | Target vessel patency assessed using change in ankle-brachial index | 30 Days |
| Peripheral Arterial Cohort | Target vessel patency assessed using change in ankle-brachial index | 90 Days |
| Peripheral Arterial Cohort | Target vessel patency assessed using change in ankle-brachial index | 180 Days |
| Peripheral Arterial Cohort | Target vessel patency assessed using change in Rutherford claudication grade | 30 Days |
| Peripheral Arterial Cohort | Target vessel patency assessed using change in Rutherford claudication grade | 90 Days |
| Peripheral Arterial Cohort | Target vessel patency assessed using change in Rutherford claudication grade | 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 | 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 | 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 | 180 Days |
| Peripheral Arterial Cohort | Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) | 90 Days |
| Peripheral Arterial Cohort | Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) | 180 Days |
| Peripheral Arterial Cohort | All-cause mortality | 30 Days |
| Peripheral Arterial Cohort | All-cause mortality | 90 Days |
| Peripheral Arterial Cohort | All-cause mortality | 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 | 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:
| 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 | 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 | 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) | 30 Days |
| Peripheral Venous Cohort | Proportion of patients demonstrating decrease in Villalta score | 90 Days |
| Peripheral Venous Cohort | Proportion of patients demonstrating decrease in Villalta score | 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. | 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. | 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. | 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 | 180 Days |
| Peripheral Venous Cohort | All-cause mortality | 30 Days |
| Peripheral Venous Cohort | All-cause mortality | 90 Days |
| Peripheral Venous Cohort | All-cause mortality | 180 Days |
| Pulmonary Embolism Cohort | Change in pulmonary artery pressure | Intraprocedural |
| Pulmonary Embolism Cohort | Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated | 48 hours |
| Pulmonary Embolism Cohort | Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated | 48 hours |
| Pulmonary Embolism Cohort | Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated | 30 Days |
| Pulmonary Embolism Cohort | Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated | 48 hours |
| Pulmonary Embolism Cohort | Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated | 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:
| 48 hours |
| Pulmonary Embolism Cohort | Right ventricle to left ventricle (RV/LV) ratio reduction from baseline | 30 days |
| Pulmonary Embolism Cohort | Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class | 90 Days |
| Pulmonary Embolism Cohort | Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class | 180 Days |
| Pulmonary Embolism Cohort | Pulmonary Embolism recurrence | 30 Days |
| Pulmonary Embolism Cohort | Pulmonary Embolism recurrence | 90 Days |
| Pulmonary Embolism Cohort | Pulmonary Embolism recurrence | 180 Days |
| Pulmonary Embolism Cohort | Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire | 30 Days |
| Pulmonary Embolism Cohort | Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire | 90 Days |
| Pulmonary Embolism Cohort | Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire | 180 Days |
| Pulmonary Embolism Cohort | All-cause mortality | 30 Days |
| Pulmonary Embolism Cohort | All-cause mortality | 90 Days |
| Pulmonary Embolism Cohort | All-cause mortality | 180 Days |
| Recruiting |
| Tampa |
| Florida |
| 33607 |
| United States |
| Midwest Cardiovascular Institute | Recruiting | Naperville | Illinois | 60540 | United States |
| Profound Research | Recruiting | Munster | Indiana | 46321 | United States |
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
| Mercy Health | Recruiting | Cincinnati | Ohio | 45242 | United States |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D011655 | Pulmonary Embolism |
| D013927 | Thrombosis |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
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