Recruiting

Symphony & Prodigy

Sponsor:

Imperative Care, Inc.

Code:

NCT07350499

Conditions

Arterial Thromboembolism

Venous Thromboembolism

Pulmonary Embolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prodigy Thrombectomy System

Symphony Thrombectomy System

Symphony Thrombectomy System

Study Details

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.

Conditions

Arterial Thromboembolism

Venous Thromboembolism

Pulmonary Embolism

Study ID

NCT07350499

Start date

Feb 13, 2026

Status verified date

Jun, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

Peripheral Arterial

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

Peripheral Venous

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

Pulmonary Embolism

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

Interventions

Prodigy Thrombectomy System

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

Symphony Thrombectomy System

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

Symphony Thrombectomy System

Removal of thrombus/emboli from the pulmonary vasculature

Primary outcome measure

  • Peripheral Arterial Cohort [ Time Frame: 30 days ]
  • Peripheral Venous Cohort [ Time Frame: 30 days ]
  • Pulmonary Embolism (PE) Cohort [ Time Frame: 30 Days ]

Central Contacts and Locations

Central contacts

Sylvie Akiel-Fu, MPH

917-375-4735safu@imperativecare.com

Locations

Huntsville Hospital

Recruiting

Huntsville, Alabama, United States, 35801

BayCare Health - St. Joseph Hospital

Recruiting

Tampa, Florida, United States, 33607

Midwest Cardiovascular Institute

Recruiting

Naperville, Illinois, United States, 60540

Profound Research

Recruiting

Munster, Indiana, United States, 46321

University At Buffalo

Recruiting

Buffalo, New York, United States, 14203

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Mercy Health

Recruiting

Cincinnati, Ohio, United States, 45242

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23502

More Information

Sponsor

Imperative Care, Inc.

Last update posted

Jul 27, 2026

Last verified

Jun, 2026

Keywords

  • Pulmonary Embolism
  • Thrombus
  • Thromboembolism
  • Aspiration
  • Aspiration thrombectomy
  • Anticoagulation
  • Peripheral vasculature

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Imperative Care, Inc. on 2026-07-27.