Arterial Thromboembolism, Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
Pulmonary Embolism, Thrombus, Thromboembolism, Aspiration, Aspiration thrombectomy, Anticoagulation, Peripheral vasculature
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.
Interventions
DEVICEProdigy Thrombectomy System
Removal of thrombus/emboli from blood vessels in the peripheral vasculature
Removal of thrombus/emboli from blood vessels in the peripheral vasculature
Sponsors
Imperative Care, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Arterial Cohort | 90 Days | Freedom from major (above-ankle) amputation of the index limb |
| Peripheral Venous Cohort | Intraprocedural | Technical success defined as complete or near complete (\>75%) reduction in Marder score from baseline to immediately after the use of the device and prior to any use of adjunctive device, as independently adjudicated |
| Pulmonary Embolism Cohort | Intraprocedural | Change in pulmonary artery pressure |
Countries
United States
Contacts
CONTACTSylvie Akiel-Fu, MPH
PRINCIPAL_INVESTIGATORSteven Abramowitz, MD
Medstar Health Research Institute
PRINCIPAL_INVESTIGATORMaya Serhal, MD
Massachusetts General Hospital
Outcome results
None listed