Prodigy Thrombectomy SystemSymphony Thrombectomy SystemSymphony Thrombectomy System
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
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Peripheral Arterial Cohort — 30 days Freedom from major (above-ankle) unanticipated amputation of the index limb
Peripheral Venous Cohort — 30 days Treated limb improvement at 30 days, defined as no unplanned intervention for breakthrough re-thrombosis and improvement in Villalta score relative to baseline.
Pulmonary Embolism (PE) Cohort — 30 Days Normal right ventricular function at 30 days follow-up, defined as tricuspid annular plane systolic excursion (TAPSE) \>1.7cm , measured on transthoracic echocardiography (TTE) and independently adjudicated.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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