NCT07350499

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Feb 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Feb 2026Sep 2030

First Submitted

Initial submission to the registry

November 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

February 13, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

March 24, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

November 21, 2025

Last Update Submit

March 23, 2026

Conditions

Arterial ThromboembolismVenous ThromboembolismPulmonary Embolism

Keywords

Pulmonary EmbolismThrombusThromboembolismAspirationAspiration thrombectomyAnticoagulationPeripheral vasculature

Outcome Measures

Primary Outcomes (3)

  • Peripheral Arterial Cohort

    Freedom from major (above-ankle) unanticipated amputation of the index limb

    30 days

  • Peripheral Venous Cohort

    Target venous patency defined as patent flow in the treated segment without ≥50% restenosis or re-occlusion, no reintervention and no re-thrombosis as assessed by duplex ultrasound or venography

    30 days

  • Pulmonary Embolism (PE) Cohort

    Mean change in the tricuspid annular plane systolic excursion to pulmonary artery systolic pressure ratio (TAPSE/PASP) from baseline, measured on transthoracic echocardiography (TTE) and independently adjudicated

    30 Days

Secondary Outcomes (45)

  • Peripheral Arterial Cohort

    90 Days

  • Peripheral Arterial Cohort

    180 Days

  • Peripheral Arterial Cohort

    30 Days

  • Peripheral Arterial Cohort

    90 Days

  • Peripheral Arterial Cohort

    180 Days

  • +40 more secondary outcomes

Study Arms (3)

Peripheral Arterial

Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature

Device: Prodigy Thrombectomy System

Peripheral Venous

Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral venous vasculature

Device: Symphony Thrombectomy System

Pulmonary Embolism

Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the pulmonary vasculature

Device: Symphony Thrombectomy System

Interventions

Prodigy Thrombectomy SystemDEVICE

Removal of thrombus/emboli from blood vessels in the peripheral vasculature

Peripheral Arterial
Symphony Thrombectomy SystemDEVICE

Removal of thrombus/emboli from blood vessels in the peripheral vasculature

Peripheral Venous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsville Hospital

Huntsville, Alabama, 35801, United States

RECRUITING

MeSH Terms

Conditions

Venous ThromboembolismPulmonary EmbolismThrombosisThromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Steven Abramowitz, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

  • Maya Serhal, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Akiel-Fu, MPH

CONTACT

917-375-4735safu@imperativecare.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

January 20, 2026

Study Start

February 13, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

March 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)