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

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: Recruiting
• Conditions: Venous Thromboembolism; Pulmonary Embolism; Arterial Thromboembolism
• Intervention / Treatment: Device: Prodigy Thrombectomy System; Device: Symphony Thrombectomy System; Device: Symphony Thrombectomy System

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Sylvie Akiel-Fu, MPH; Phone Number: 917-375-4735; Email: safu@imperativecare.com

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
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • Mercy Health

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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	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: Major bleeding; Device-related mortality; Device-related Serious Adverse Events (SAE)	48 hours
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	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	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	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
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 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	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
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
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	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

• Sponsor: Imperative Care, Inc.
• Investigators: Principal Investigator: Steven Abramowitz, MD, Medstar Health Research Institute; Principal Investigator: Maya Serhal, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: January 10, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Anticoagulation; Thrombus; Aspiration; Thromboembolism; Pulmonary Embolism; Aspiration thrombectomy; Peripheral vasculature
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID 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