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
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