Aspiration Thrombectomy Using the Symphony or Prodigy System (CLEAR-IT)

July 23, 2026 updated by: Imperative Care, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Huntsville Hospital
    • Florida
      • Tampa, Florida, United States, 33607
        • Recruiting
        • BayCare Health - St. Joseph Hospital
    • Illinois
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Midwest Cardiovascular Institute
    • Indiana
      • Munster, Indiana, United States, 46321
        • Recruiting
        • Profound Research
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Mercy Health
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Sentara Norfolk General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Subject is ≥ 18 years of age
  2. Subject is willing and able to comply with the follow-up schedule specified in this protocol
  3. Subject is willing and able to provide written informed consent prior to any study-related data collection
  4. Subject has a planned procedure, involving the use of Imperative Care vascular devices within their intended use

Exclusion Criteria:

  1. Subjects with any contraindications per the applicable Instructions for Use
  2. Subject with life expectancy of less than 1 year
  3. In the opinion of the Investigator, the patient is not a suitable candidate for intervention with Imperative Care devices
  4. Subject who may be unable to complete study follow-up
  5. Peripheral Venous Cohort ONLY: Presence of thrombus extending more than 2 cm into the IVC on imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Peripheral Arterial
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature
Device: Prodigy Thrombectomy System
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
Device: Symphony Thrombectomy System
Removal of thrombus/emboli from blood vessels in the peripheral vasculature
Device: Symphony Thrombectomy System
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
Device: Symphony Thrombectomy System
Removal of thrombus/emboli from blood vessels in the peripheral vasculature
Device: Symphony Thrombectomy System
Removal of thrombus/emboli from the pulmonary vasculature

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peripheral Arterial Cohort
Time Frame: 30 days
Freedom from major (above-ankle) unanticipated amputation of the index limb
30 days
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.
30 days
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.
30 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peripheral Arterial Cohort
Time Frame: 90 Days
Freedom from major (above-ankle) amputation of the index limb
90 Days
Peripheral Arterial Cohort
Time Frame: 180 Days
Freedom from major (above-ankle) amputation of the index limb
180 Days
Peripheral Arterial Cohort
Time Frame: 30 Days
Major adverse cardiovascular events (MACE) rate
30 Days
Peripheral Arterial Cohort
Time Frame: 90 Days
Major adverse cardiovascular events (MACE) rate
90 Days
Peripheral Arterial Cohort
Time Frame: 180 Days
Major adverse cardiovascular events (MACE) rate
180 Days
Peripheral Arterial Cohort
Time Frame: 30 Days
Target vessel patency assessed using change in ankle-brachial index
30 Days
Peripheral Arterial Cohort
Time Frame: 90 Days
Target vessel patency assessed using change in ankle-brachial index
90 Days
Peripheral Arterial Cohort
Time Frame: 180 Days
Target vessel patency assessed using change in ankle-brachial index
180 Days
Peripheral Arterial Cohort
Time Frame: 30 Days
Target vessel patency assessed using change in Rutherford claudication grade
30 Days
Peripheral Arterial Cohort
Time Frame: 90 Days
Target vessel patency assessed using change in Rutherford claudication grade
90 Days
Peripheral Arterial Cohort
Time Frame: 180 Days
Target vessel patency assessed using change in Rutherford claudication grade
180 Days
Peripheral Arterial Cohort
Time Frame: 30 Days
All-cause mortality
30 Days
Peripheral Arterial Cohort
Time Frame: 90 Days
All-cause mortality
90 Days
Peripheral Arterial Cohort
Time Frame: 180 Days
All-cause mortality
180 Days
Peripheral Venous Cohort
Time Frame: 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
Time Frame: 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:

  • Major bleeding
  • Device-related mortality
  • Device-related Serious Adverse Events (SAE)
48 hours
Peripheral Venous Cohort
Time Frame: 90 Days
Proportion of patients demonstrating decrease in Villalta score
90 Days
Peripheral Venous Cohort
Time Frame: 180 Days
Proportion of patients demonstrating decrease in Villalta score
180 Days
Peripheral Venous Cohort
Time Frame: 30 Days
All-cause mortality
30 Days
Peripheral Venous Cohort
Time Frame: 90 Days
All-cause mortality
90 Days
Peripheral Venous Cohort
Time Frame: 180 Days
All-cause mortality
180 Days
Pulmonary Embolism Cohort
Time Frame: Intraprocedural
Change in pulmonary artery pressure
Intraprocedural
Pulmonary Embolism Cohort
Time Frame: 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:

  • Major bleeding
  • Device-related mortality
  • Device-related Serious Adverse Events (SAE)
48 hours
Pulmonary Embolism Cohort
Time Frame: 30 days
Right ventricle to left ventricle (RV/LV) ratio reduction from baseline
30 days
Pulmonary Embolism Cohort
Time Frame: 90 Days
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class
90 Days
Pulmonary Embolism Cohort
Time Frame: 180 Days
Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class
180 Days
Pulmonary Embolism Cohort
Time Frame: 30 Days
Pulmonary Embolism recurrence
30 Days
Pulmonary Embolism Cohort
Time Frame: 90 Days
Pulmonary Embolism recurrence
90 Days
Pulmonary Embolism Cohort
Time Frame: 180 Days
Pulmonary Embolism recurrence
180 Days
Pulmonary Embolism Cohort
Time Frame: 30 Days
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
30 Days
Pulmonary Embolism Cohort
Time Frame: 90 Days
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
90 Days
Pulmonary Embolism Cohort
Time Frame: 180 Days
Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
180 Days
Pulmonary Embolism Cohort
Time Frame: 30 Days
All-cause mortality
30 Days
Pulmonary Embolism Cohort
Time Frame: 90 Days
All-cause mortality
90 Days
Pulmonary Embolism Cohort
Time Frame: 180 Days
All-cause mortality
180 Days
Peripheral Arterial Cohort
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 90 Days
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)
90 Days
Peripheral Arterial Cohort
Time Frame: 180 Days
Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)
180 Days
Peripheral Venous Cohort
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Pulmonary Embolism Cohort
Time Frame: 48 hours
Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated
48 hours
Pulmonary Embolism Cohort
Time Frame: 48 hours
Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated
48 hours
Pulmonary Embolism Cohort
Time Frame: 30 Days
Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated
30 Days
Pulmonary Embolism Cohort
Time Frame: 48 hours
Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated
48 hours
Pulmonary Embolism Cohort
Time Frame: 30 Days
Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated
30 Days
Peripheral Venous Cohort
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperative Care, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven Abramowitz, MD, Medstar Health Research Institute
  • Principal Investigator: Maya Serhal, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICI-2025-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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