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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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
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 the pulmonary vasculature

Recruiting Locations

Huntsville Hospital
Huntsville, Alabama 35801

BayCare Health - St. Joseph Hospital
Tampa, Florida 33607

Profound Research
Munster, Illinois 46321

Mercy Health
Cincinnati, Ohio 45242

More Details

Status
Recruiting
Sponsor
Imperative Care, Inc.

Study Contact

Sylvie Akiel-Fu, MPH
917-375-4735
safu@imperativecare.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.