An observational study in Arterial Thromboembolism, Venous Thromboembolism and Pulmonary Embolism, sponsored by Imperative Care, Inc.. Recruiting at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Imperative Care, Inc. · Observational
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.
712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.
This study's planned enrollment of 750 is close to the median of 700 across 282 observational studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Imperative Care, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature
Device: Prodigy Thrombectomy System
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral venous vasculature
Device: Symphony Thrombectomy System
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the pulmonary vasculature
Device: Symphony Thrombectomy System
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
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
Peripheral 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
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Imperative Care, Inc.