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NCT07350499Recruiting

Aspiration Thrombectomy Using the Symphony or Prodigy System

Imperative Care, Inc.

Start Date

2/13/2026

Completion Date

9/1/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Prodigy Thrombectomy System

DEVICE

Symphony Thrombectomy System

DEVICE

Symphony Thrombectomy System

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Conditions

Arterial ThromboembolismVenous ThromboembolismPulmonary Embolism

Locations

Huntsville Hospital

Huntsville, Alabama 35801

United States

BayCare Health - St. Joseph Hospital

Tampa, Florida 33607

United States

Midwest Cardiovascular Institute

Naperville, Illinois 60540

United States

Profound Research

Munster, Indiana 46321

United States

University At Buffalo

Buffalo, New York 14203

United States

Mount Sinai Hospital

New York, New York 10029

United States

Mercy Health

Cincinnati, Ohio 45242

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23502

United States