Arterial ThromboembolismCLEAR-ITNCT07350499
Aspiration Thrombectomy Using the Symphony or Prodigy System
An observational study of Arterial Thromboembolism and Venous Thromboembolism, run by Imperative Care, Inc. at 13 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Thromboembolism, Venous Thromboembolism, Pulmonary Embolism
- What is being tested?
- Prodigy Thrombectomy System and Symphony Thrombectomy System
- Type of treatment
- Medical device
- How many people
- 750 participants
- Where
- 13 sitesUnited States
- Study dates
- 13 Feb 2026to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
University At Buffalo
Buffalo, New York, 14203
- Recruiting
Mercy Health
Cincinnati, Ohio, 45242
- Recruiting
BayCare Health System- Morton Plant Hospital
Clearwater, Florida, 33756
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
- Recruiting
Medical City Fort Worth Hospital
Fort Worth, Texas, 761104
- Recruiting
Huntsville Hospital
Huntsville, Alabama, 35801
- Recruiting
HCA Florida Memorial Hospital
Jacksonville, Florida, 32216
- Recruiting
Profound Research
Munster, Indiana, 46321
- Recruiting
Midwest Cardiovascular Institute
Naperville, Illinois, 60540
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23502
- Recruiting
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
- Recruiting
BayCare Health System - St. Joseph Hospital
Tampa, Florida, 33607
About this study
Official title: Long-Term CLinical Evaluation of Aspiration ThRombectomy Using the Symphony or ProdIgy Thrombectomy System - 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.
- Being tested
- Prodigy Thrombectomy System, Symphony Thrombectomy System
- Keywords
- Pulmonary Embolism, Thrombus, Thromboembolism, Aspiration, Aspiration thrombectomy, Anticoagulation, Peripheral vasculature
- Medical subject headings
- Venous Thromboembolism, Pulmonary Embolism, Thrombosis, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prodigy Thrombectomy SystemDevice
Removal of thrombus/emboli from blood vessels in the peripheral vasculature
Symphony Thrombectomy SystemDevice
Removal of thrombus/emboli from blood vessels in the peripheral vasculature
Symphony Thrombectomy SystemDevice
Removal of thrombus/emboli from the pulmonary vasculature
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Arterial | Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature Receives: Device: Prodigy Thrombectomy System | |
| Peripheral Venous | Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral venous vasculature Receives: Device: Symphony Thrombectomy System | |
| Pulmonary Embolism | Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the pulmonary vasculature Receives: Device: Symphony Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Arterial Cohort
Freedom from major (above-ankle) unanticipated amputation of the index limb
Measured: 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.
Measured: 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.
Measured: 30 Days
Secondary outcomes (52)
Peripheral Arterial Cohort
Freedom from major (above-ankle) amputation of the index limb
Measured: 90 Days
Peripheral Arterial Cohort
Freedom from major (above-ankle) amputation of the index limb
Measured: 180 Days
Peripheral Arterial Cohort
Major adverse cardiovascular events (MACE) rate
Measured: 30 Days
Peripheral Arterial Cohort
Major adverse cardiovascular events (MACE) rate
Measured: 90 Days
Peripheral Arterial Cohort
Major adverse cardiovascular events (MACE) rate
Measured: 180 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in ankle-brachial index
Measured: 30 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in ankle-brachial index
Measured: 90 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in ankle-brachial index
Measured: 180 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in Rutherford claudication grade
Measured: 30 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in Rutherford claudication grade
Measured: 90 Days
Peripheral Arterial Cohort
Target vessel patency assessed using change in Rutherford claudication grade
Measured: 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
Measured: 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
Measured: 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
Measured: 180 Days
Peripheral Arterial Cohort
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)
Measured: 90 Days
Peripheral Arterial Cohort
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)
Measured: 180 Days
Peripheral Arterial Cohort
All-cause mortality
Measured: 30 Days
Peripheral Arterial Cohort
All-cause mortality
Measured: 90 Days
Peripheral Arterial Cohort
All-cause mortality
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 30 Days
Peripheral Venous Cohort
Proportion of patients demonstrating decrease in Villalta score
Measured: 90 Days
Peripheral Venous Cohort
Proportion of patients demonstrating decrease in Villalta score
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 180 Days
Peripheral Venous Cohort
All-cause mortality
Measured: 30 Days
Peripheral Venous Cohort
All-cause mortality
Measured: 90 Days
Peripheral Venous Cohort
All-cause mortality
Measured: 180 Days
Pulmonary Embolism Cohort
Change in pulmonary artery pressure
Measured: Intraprocedural
Pulmonary Embolism Cohort
Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated
Measured: 48 hours
Pulmonary Embolism Cohort
Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated
Measured: 48 hours
Pulmonary Embolism Cohort
Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated
Measured: 30 Days
Pulmonary Embolism Cohort
Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated
Measured: 48 hours
Pulmonary Embolism Cohort
Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated
Measured: 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)
Measured: 48 hours
Pulmonary Embolism Cohort
Right ventricle to left ventricle (RV/LV) ratio reduction from baseline
Measured: 30 days
Pulmonary Embolism Cohort
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class
Measured: 90 Days
Pulmonary Embolism Cohort
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class
Measured: 180 Days
Pulmonary Embolism Cohort
Pulmonary Embolism recurrence
Measured: 30 Days
Pulmonary Embolism Cohort
Pulmonary Embolism recurrence
Measured: 90 Days
Pulmonary Embolism Cohort
Pulmonary Embolism recurrence
Measured: 180 Days
Pulmonary Embolism Cohort
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
Measured: 30 Days
Pulmonary Embolism Cohort
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
Measured: 90 Days
Pulmonary Embolism Cohort
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
Measured: 180 Days
Pulmonary Embolism Cohort
All-cause mortality
Measured: 30 Days
Pulmonary Embolism Cohort
All-cause mortality
Measured: 90 Days
Pulmonary Embolism Cohort
All-cause mortality
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start13 Feb 2026
- Primary completionMar 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperative Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Abramowitz, MD, Principal investigator, Medstar Health Research InstituteMaya Serhal, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350499
- Sponsor's protocol ID
- ICI-2025-002
- Acronym
- CLEAR-IT
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term CLinical Evaluation of Aspiration ThRombectomy Using the Symphony or ProdIgy Thrombectomy System - CLEAR-IT
- ClinicalTrials.gov ID
- NCT07350499
- Acronym / sponsor ID
- CLEAR-IT / ICI-2025-002
- Keywords
- Pulmonary Embolism, Thrombus, Thromboembolism, Aspiration, Aspiration thrombectomy, Anticoagulation, Peripheral vasculature
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Imperative Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peripheral Arterial | – | Device: Prodigy Thrombectomy SystemSubjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature |
| Peripheral Venous | – | Device: Symphony Thrombectomy SystemSubjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral venous vasculature |
| Pulmonary Embolism | – | Device: Symphony Thrombectomy SystemSubjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the pulmonary vasculature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prodigy Thrombectomy SystemRemoval of thrombus/emboli from blood vessels in the peripheral vasculature | Device | Peripheral Arterial |
| Symphony Thrombectomy SystemRemoval of thrombus/emboli from blood vessels in the peripheral vasculature | Device | Peripheral Venous |
| Symphony Thrombectomy SystemRemoval of thrombus/emboli from the pulmonary vasculature | Device | Pulmonary Embolism |
Primary outcome
Peripheral Arterial Cohort
Time frame: 30 days
Freedom from major (above-ankle) unanticipated amputation of the index limb
Peripheral Venous Cohort
Time frame: 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.
Pulmonary Embolism (PE) Cohort
Time frame: 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.
52 secondary outcomes
Peripheral Arterial Cohort
Time frame: 90 Days
Peripheral Arterial Cohort
Time frame: 180 Days
Peripheral Arterial Cohort
Time frame: 30 Days
Peripheral Arterial Cohort
Time frame: 90 Days
Peripheral Arterial Cohort
Time frame: 180 Days
Peripheral Arterial Cohort
Time frame: 30 Days
Peripheral Arterial Cohort
Time frame: 90 Days
Peripheral Arterial Cohort
Time frame: 180 Days
Peripheral Arterial Cohort
Time frame: 30 Days
Peripheral Arterial Cohort
Time frame: 90 Days
Peripheral Arterial Cohort
Time frame: 180 Days
Peripheral Arterial Cohort
Time frame: 30 Days
Peripheral Arterial Cohort
Time frame: 90 Days
Peripheral Arterial Cohort
Time frame: 180 Days
Peripheral Arterial Cohort
Time frame: 90 Days
Peripheral Arterial Cohort
Time frame: 180 Days
Peripheral Arterial Cohort
Time frame: 30 Days
Peripheral Arterial Cohort
Time frame: 90 Days
Peripheral Arterial Cohort
Time frame: 180 Days
Peripheral Venous Cohort
Time frame: Intraprocedural
Peripheral Venous Cohort
Time frame: 48 hours
Peripheral Venous Cohort
Time frame: 90
Peripheral Venous Cohort
Time frame: 180
Peripheral Venous Cohort
Time frame: 30 Days
Peripheral Venous Cohort
Time frame: 90 Days
Peripheral Venous Cohort
Time frame: 180 Days
Peripheral Venous Cohort
Time frame: 30 Days
Peripheral Venous Cohort
Time frame: 60 Days
Peripheral Venous Cohort
Time frame: 180 Days
Peripheral Venous Cohort
Time frame: 180 Days
Peripheral Venous Cohort
Time frame: 30 Days
Peripheral Venous Cohort
Time frame: 90 Days
Peripheral Venous Cohort
Time frame: 180 Days
Pulmonary Embolism Cohort
Time frame: Intraprocedural
Pulmonary Embolism Cohort
Time frame: 48 hours
Pulmonary Embolism Cohort
Time frame: 48 hours
Pulmonary Embolism Cohort
Time frame: 30 Days
Pulmonary Embolism Cohort
Time frame: 48 hours
Pulmonary Embolism Cohort
Time frame: 30 Days
Pulmonary Embolism Cohort
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Abramowitz, MD principal investigator
Medstar Health Research Institute
Maya Serhal, MD principal investigator
Massachusetts General Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Thromboembolism and Venous Thromboembolism, run by Imperative Care, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Akiel-Fu, MPH (917-375-4735, safu@imperativecare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Arterial Cohort (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.